Straddle Mitral Valve Device and Methods

ABSTRACT

A method for providing blood flow across a surface of a mitral stent-valve frame. A portion of the stent-valve frame is placed into the left atrium and into the left ventricle with a securement band located intermediate that is attached to either the annulus or to a second support frame that is placed initially and above the mitral annulus without affecting native leaflet function. Portions of the frame above the securement band allow blood flow radially inwards to reduce stagnation regions in the atrium or outwards below the securement band to help cleanse native leaflets.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of application Ser. No.16/147,823 filed 30 Sep. 2018, entitled Straddle Annular Mitral Valve byWilliam J. Drasler and William J. Drasler II, the entire content ofwhich is hereby incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Valves of the heart including the aortic valve, mitral valve, andtricuspid valve can become hardened from atherosclerotic plaque andcalcium and no longer function normally. Alternately these valve canprolapse and allow blood to pass through the valve in a retrogrademanner that is opposite to the normal direction of flow through thevalve. Such regurgitant flow can require repair or replacement of thevalve. Surgical repair or replacement of such valve is often the goldstandard at present for those patients able to withstand the rigors ofsurgery. An alternate and less invasive approach would be desirable viaaccess to the valve from the femoral vasculature, vasculature of thearms, the apex of the heart, aortic access, or via other less invasivesites.

Transcatheter aortic valve replacement (TAVR) has evolved to become anaccepted less invasive procedure for replacing diseased or incompetentaortic valves in high risk patients. Such less invasive surgicalprocedures are not as well developed for replacing abnormallyfunctioning mitral valves.

Often the regurgitant mitral valve is a result of excessive expansion ofthe left ventricle (LV) leading to abnormal tension and angulationimposed on the mitral valve leaflet. The mitral valve leaflet is oftenunable to coapt properly with its neighboring leaflet and will thereinallow retrograde blood flow to occur through the valve. The mitral valveannulus is more elastic, in part, than the aortic annulus and can expandin diameter reducing the ability of the mitral valve leaflets to coaptproperly; one should not expand a stent into the mitral annulus to pushit further outwards as is done with TAVR procedures onto the aorticvalve annulus.

The mitral anatomy also provides that the anterior mitral leaflet notonly helps close the mitral annulus during systole, but also providesone surface of the left ventricular outflow track (LVOT) during systolicpumping of blood out of the LV. It is therefore not acceptable to expanda stent indiscriminately outwards as is done in TAVR due to thepotential for blockage of the LVOT by the anterior mitral valve leaflet.

The use of barbs or other fixation members to hold the TMVR devicesecurely to the native mitral apparatus can create a set of potentialclinical issues that are problematic to the patient. Expansion of barbsprior to full apposition of the TMVR stent against the mitral annulus,for example, can obviate the ability of the barbs to position themselvesand the stent-valve frame uniformly around the perimeter of the mitralannulus. Furthermore, activation of barbs via a standard dilationballoon can block blood flow through the mitral annulus during ballooninflation causing the patient to temporarily go without oxygen supply tothe brain with its ensuing consequences. Additionally, inflation of astandard balloon can cause the positioning of the stent-valve to becomeinstantaneously displaced and hence inappropriately located across themitral annulus due to blood pressure and blood flow generated by the LV.

The delivery profile of TMVR devices is generally greater than those forTAVR due to the larger diameter of the mitral annulus in comparison tothe aortic annulus. This profile limitation has forced many of the TMVRdevices to be delivered via the apex of the heart rather than through amore favorable transvascular and transseptal delivery approach. Theapical approach is not well suited to patients that are older in age orare of higher risk. What is needed is a TMVR device that is of a lowerprofile such that it can be delivered via a transvascular andtransseptal approach. The device should be easily positioned across themitral annulus and secured to the native mitral apparatus without chancefor device migration. The TMVR device should eliminate regions for bloodstagnation that can lead to thromboemboli that could potentially resultin stroke and should not restrict blood flow out of the LVOT.

Due to the potential for the replacement leaflets or frame of a TMVRdevice impeding blood flow through the LVOT, or impingement of the TMVRframe onto the native leaflets causing them to impede blood flow throughthe LVOT an advantage exists for locating the TMVR device in part in theLD and in part in the LV, or totally within the left atrium (LA). Whenlocating a portion the TMVR above (i.e., toward the LA) the mitralannulus care must be taken to ensure that blood flow from the LA cannotform regions of stagnation that can lead to the formation ofthromboemboli which can embolize to the brain and can lead to stroke.Locating other replacement valves of the heart at locations that aremore upstream of the valve annulus can also provide benefits that areprovided by the present invention. An advantage exists for positioningat least a portion of the stent-valve frame upstream of the native heartvalve annulus; such positioning can reduce the stent-valve frame portionof the that is downstream of the annulus from impingement upon the LVOTor pushing the native valve leaflets into the LVOT. Locating the TMVRdevice substantially within the LA without having an extension ofseveral millimeters of the stent-valve frame into the LV can alsopresent negative sequellae. Without the stent-valve frame extending intothe LV, the native leaflets can overhang into the replacementstent-valve and can interfere with stent-valve function. Stent-valvesthat are placed across the mitral annulus should reduce regions of bloodstagnation that can occur upstream of the native annulus and downstreamof the native annulus. What is needed is a stent-valve that does notcause impingement onto the LVOT and does not allow the native leafletsto interfere with the function of the replacement leaflets. Bloodstagnation should be eliminated in the LA and in the LV such thatthrombus formation and release of thromboemboli have been prevented.

SUMMARY

Embodiments of the present invention contain a stent that is expandedvia a mechanical means such as a balloon; other embodiments are formedfrom a self-expanding material and are released via withdrawal of asheath in a manner similar to that taken with current TAVR devices. Thestent-valve devices of the present invention are intended for use in themitral valve, aortic valve, tricuspid valve, and pulmonary valve of theheart; the devices can also be used in other applications to secure animplanted devices within a vessel or lumen of the body where blockage ofblood flow through the lumen or vessel is not desired during theimplantation of the stent-valve device or other implanted device in thevessel or lumen. Although much of the discussion presented in thisapplication is directed toward implantation of a stent-valve device inthe mitral position, it is understood that the stent-valve device orother device suitable for implantation within the body can equally beapplied to other valvular positions, vascular positions, or luminalpositions of the body with consideration given to adjust the size orprofile of the device and the access location into the vasculature orlumen of the tissue that is undergoing the implantation of the device.

In one embodiment the device is a single member stent-valve that is ableto be used for Transcatheter Mitral Valve Replacement (TMVR) has a SEstent frame with a cylindrically-shaped or a curved waist portion and anupper bulb that is attached to the waist. This waist portion makesdirect contact with the mitral annulus and ensures a tight seal againstthe mitral annulus; the upper stent bulb extends into the left atrium(LA) and outwards against the wall of the into the LA to provideadditional seal against the LA to mitral annulus junction and to healinto the tissues above the mitral annulus to ensure that the mitralannulus does not expand further over time. The waist of the SE stentframe can have a limiting cable attached around its perimeter to ensurethat the waist cannot expand further beyond a prescribed perimeter uponrelease from an delivery sheath that can ensure that an outward force isnot being continuously applied to the mitral annulus. The outward forceexerted by the SE waist to reach its full perimeter and expand themitral annulus outward to a round shape can also be increased beyond theforces normally applied by a standard SE stent frame due to the presenceof a limiting cable.

In one embodiment a stent frame housing is attached to the waist of thestent frame and extends into the left ventricle (LV) to provide ahousing for the replacement leaflets. The replacement leaflets areformed from a tissue material, a synthetic polymeric material, or acomposite material which can include a metal such as Nitinol (NiTi); thereplacement leaflets are formed from a material that can be implantedwithin the body for periods of years without degradation or causing anadverse reaction to the body. The housing of this invention can have ashape of a cone that has its top cut off forming a frustum; the top ofthe frustum extending on the downstream or outflow end of the housingthat is closest to the apex of the heart. The smaller diameter of theoutflow end provides two major advantages. First, the frustum-like shapedoes not push the native anterior leaflet of the mitral valve outwardsinto the LVOT which can impede blood flow out of the LV. Second, thefrustum-shaped housing also allows the native mitral leaflets to beadequately exposed to blood flow across the native mitral leafletsurfaces (the inner flow surfaces that contact the blood flow from theLA to the LV and the outer surfaces that faces the myocardial wall) suchthat thrombosis is not generated and thromboemboli are not released withpotential migration to the brain and resultant stroke.

The leaflets contained within the frustum-shaped housing can have afrustum-like shape. The replacement leaflets form a crown-like shapedattachment to the frustum-shaped housing; the nadirs of the crown-shapedattachment at the base of the leaflets forms a perimeter at the base ofthe housing that is significantly larger than the perimeter of thehousing at the outflow end of the housing. The free edges of thereplacement leaflets do not come into direct contact with the top of thefrustum-shaped housing at the outflow end; the spacing between the freeedges of the replacement leaflets from the housing allows blood flow torinse the leaflets during diastole and prevent thrombosis fromoccurring.

A fabric or covering is attached to some or all of the SE stent portionof the housing to prevent regurgitant flow through the TMVR; thecovering can extend throughout the entire stent structure, including thewaist, upper bulb, and housing portions to ensure that retrograde bloodleakage is not obtained. The covering can be formed from a fabricmaterial such as a woven or knitted fabric or a polymeric sheetmaterial; the material for the fabric can be nondistendable fabric suchas PET or Nylon that resists expansion of the covering upon exposure toexpansion forces. Alternately, the covering can be formed in someembodiments from an expandable material such as polyurethane or spandexthat will allow expansion of the covering; the restraining forces from alimiting cable attached along a perimeter of the waist or housing canserve to limit excessive expansion of the housing beyond a specifieddiameter and is necessary to maintain replacement leaflet coaptation.

The replacement leaflets contained within and attached to the housingportion of the stent can form a bileaflet valve similar to that found inthe venous system or native mitral valve of the body, or the replacementleaflets can form a trileaflet valve similar to that found in a nativeaortic valve. The material for the valve leaflets can be bovine,porcine, or other animal pericardium or other tissue, collagen, fibrin,or other valve material including polymeric or composite materials usedor anticipated for use in replacement valves. Alternately, a syntheticvalve material can be used including material such as polyurethane,ePTFE, NiTi, or composite materials used in implanted devices.Attachment of the leaflets to the housing portion of the stent follows acurved or crown-shaped path that is similar to that found in theattachment of aortic valve leaflets or venous valve leaflets to theirrespective conduit. Polymeric or metal fibers or members can becontained within the leaflet structure or attached to the leafletstructure to provide both structural strength and provide flexingcharacteristics to the leaflets and also assist as members that can bedirectly attached to the stent frame. The crown-shaped attachment of theleaflets of the present invention can have a frustum-like shape in therespect that the base of the leaflets follows a perimeter that is largerthan the perimeter of the free edge of the leaflets by at least 30%.Bileaflet replacement mitral valve leaflets are also anticipated for usewith the present invention, a bileaflet valve can be oriented such thatthe major axis of the native mitral annulus is oriented with thecommissures of the bileaflet valve to allow for improved coaptation ofthe leaflets over a greater range of ovality of the mitral annulus andresult in less regurgitation and improved durability for the replacementleaflets.

The waist, upper bulb, and housing portion of the stent frame can beformed from any stent geometry such as open-cell or closed-cell stentwall construction. An additional expansion limitation element—such as alimiting cable may be placed into the stent geometric structure thatlimits the amount of radial expansion that the waist portion or thehousing can attain. The upper bulb portion of the frame on the LA sideof the waist is able to expand freely and extend in diameter furtherthan the waist.

Balloon expandable (BE) or self-expanding (SE) barbs are located alongthe perimeter of the waist of embodiments of the present invention toprovide fixation of the stent frame to the mitral annulus. In oneembodiment, the barbs are formed from a BE material such as stainlesssteel, for example. The BE barbs remain in an inactive configurationuntil the waist is expanded into contact with the mitral annulus. Apost-dilation step is then performed using an expandable or dilationballoon to push against the BE barbs and activate them into aconfiguration that engages the tip of the barb with the tissues of themitral annulus. The barbs, when activated, provide stability to thestent frame against migration toward the LA due to blood pressure andflow generated by the LV.

A dilation balloon used for delivery or expansion of specificembodiments of the present invention can be formed from a shape having adiameter approximately equal to that of the mitral annulus in the waistportion and an alternate diameter that matches the shape and diameter ofthe stent frame and tissue structure in another portion. The balloon canhave a torus or doughnut shape to allow blood flow across the annuluswith the balloon inflated. The delivery system for some specificembodiments may include such a balloon to dilate various components ofthe present invention.

In another embodiment for fixation of the stent frame to the annulus thebarbs are formed from a SE material; the SE barbs (formed from NiTi, forexample) are held by a control fiber in an inactive position until thewaist has been positioned against the annulus and has been fullyexpanded to its final diameter. The barbs can be released or activatedby applying tension to the control fiber once the waist of the stentframe has been determined to be positioned accurately adjacent theannulus.

In yet another embodiment the valve of the present invention consists ofa dual member stent-valve formed from two components that are deliveredseparately. The first component or support member contains a waist thatforms a portion of the stent frame that is firmly attached to the mitralannulus (via barbs) and forms an outer ring structure into which asmaller diameter stent-valve can be placed; the outer ring structure canbe formed by a limiting cable that is placed along the perimeter of thestent frame. The first component provides a fixed perimeter that holds asecond component stent-valve via a frictional fit or via geometriclocking of the first and second components. The first component forms anadapter that allows a second component (containing the replacementleaflets) to be implanted within its open central lumen as a secondstep. The embodiment for the first component that is comprised of awaist or waist frame is intended to allow complete unobstructed functionof the native valve leaflets (by locating the stent frame waist acrossthe mitral annulus and above the native mitral leaflets, for example)until the second component is inserted into and attached to the firstcomponent. Alternately, an upper bulb and/or a housing can be attachedto the waist to form the first component. The stent frame is deliveredto the location requiring a replacement valve contained in a smalldiameter non-deployed configuration within a sheath. The SE waist isreleased from the sheath and allowed to expand adjacent the mitralannulus; the stent frame has an upper bulb located above the waist inthe LA to assist with positioning the stent frame waist across theannulus. The upper bulb has a larger diameter than the waist to preventmigration of the valve toward the LV and to provide a seal between thestent frame and the wall of the LA and mitral annulus. The equilibriumwaist diameter is sized to be slightly larger (approximately 2 mmlarger) than the effective diameter of the annulus to ensure that itmakes direct contact along the entire perimeter of the mitral annulusand prevents leakage between the stent frame and the mitral annulus.

The second component of this embodiment is a stent-valve; thestent-valve having an expandable stent frame and replacement leafletsattached to the stent frame. In one embodiment the stent-valve has afrustum-like shape frame body that houses the replacement leaflets andhaving a smaller diameter at the outflow end of the frustum-shaped bodyby 30% (range 25-35%) than the diameter of the mitral valve annulus orthe diameter of the inflow end of its frustum-shaped body. Thestent-valve can be a modified TAVR device or a stent-valve with afrustum-like or hyperboloid-like shape for its frame. A TAVR device canbe modified to form a frustum-like second component that is inserted andplaced into the housing of the first component of the present invention.For example, the skirt or covering of a stent-valve device could beremoved such that the covering of the first component housing serves toprovide the function of preventing leakage of blood past the valveleaflets of the stent-valve device. The second component is deliveredafter the first component has been successfully positioned and attachedacross the mitral annulus.

In another embodiment the second component can be a cylindrically shapedstent-valve similar to some stent-valves used for TAVR implantation. Thecylindrically shaped stent-valve can be held into contact with the firstcomponent via friction, geometric, or locking members to the waist ofthe first component. In one embodiment the SE waist of the secondcomponent is positioned adjacent to the waist of the first component.Release of the frustum-shaped stent-valve body of the second componentis accomplished by removal of an external sheath that was holding the SEstent-valve and its contained replacement leaflets in a collapsedconfiguration. In another embodiment the second component could beformed instead from a BE stent body and delivered to the first componenthousing via mounting onto a dilation balloon that is shaped to fitwithin the first component housing.

The diameter of a mitral valve annulus is typically 35 mm and rangesfrom 28-40 mm in most patients; some patients could have an enlargedmitral valve annulus that is larger than 48 mm; some mitral annulus canbe as small as 25 mm. The stent frame of the first component of thepresent embodiment has a waist that is located adjacent the mitralannulus and is approximately 35 mm for an average diameter to match thediameter of the mitral annulus. The aortic valve annulus issignificantly smaller than the mitral valve annulus with an averagediameter of approximately 24 mm and ranging from 19-29 mm. The use of alimiting cable located within a curved waist of the first component; thecurved waist having a convex shape that extends into the open lumen ofthe first component provides a locking member for frictional orgeometrical locking of the first component with the second component;the second component having a small 25 mm stent frame diameter that issimilar to the diameter of a TAVR device

The activation of BE fixation elements such as BE barbs to hold thestent frame from migration can be accomplished using a torus-shapedballoon (i.e., torus balloon) rather than a standard large diametercylindrically-shaped dilation balloon. The torus balloon has a centralopening similar to the opening of a doughnut that allows blood flow tocross the balloon without impeding flow through the mitral annulus. Thecentral opening of the torus balloon allows the BE barbs to be activatedwhile blood flow through the mitral annulus is maintained withoutblockage as would be imposed by a cylindrical or conically shapedballoon without a central opening.

The torus balloon of one embodiment of the present invention is attachedto the waist or other region of the stent frame and saline is used toinflate the torus balloon after the waist portion of the stent frame ispositioned properly adjacent to the mitral annulus. The inflated torusballoon pushes the fixation elements or fixation barbs outward intopenetration within the mitral annulus. Prior to inflation of theballoon, the stent frame can be withdrawn into the delivery tube andrepositioned across the mitral annulus, if necessary. Upon activation ofthe BE barbs, the inflation fluid delivery tube is detached from thetorus balloon and the inflation tube is removed from the device. Thesaline inflation fluid is allowed to leak out of the torus balloonallowing the torus balloon to return to a flattened deflatedconfiguration and the torus balloon can be implanted along with thestent frame.

In one embodiment the torus balloon is intended to be attached to thestent frame and is implanted along with the stent frame into the tissuesof the heart. In another embodiment, the torus balloon is removable fromthe stent frame such that the torus balloon can first be inflated toactivate the BE barbs and then be removed from the tissues of the bodythereby leaving the other portions of the stent valve implanted adjacentthe mitral annulus of the heart.

In another embodiment of the mitral valve device SE fixation elementsare held in an inactive configuration toward the inside or luminal sideof the stent frame. A feature that is formed onto the barb is designedto interface with a control fiber that holds the SE barb in an inactiveconfiguration. Upon release of the control fiber via application of atension force in the control fiber, the SE barb springs back to itsequilibrium configuration with the barb extending outwards to theoutside of the stent frame and into the mitral annulus. The bards extendinto the mitral annulus along a perimeter of the mitral annulus. Theirdepth of penetration into the mitral annulus is less than the depth thatwould allow penetration into the circumflex artery that could otherwisecause negative sequellae.

In another embodiment the torus balloon can be formed with a segmentedconfiguration formed from a series of larger diameter spherical segmentsseparated by a series of smaller diameter cylindrical segments. Thelarger diameter spherical segments are placed adjacent to the inside ofthe barb struts to push the barbs outwards upon inflation of thesegmented torus balloon. The smaller diameter cylindrical segmentsconnect each spherical segment to each other and also the balloon portto provide an inflation lumen through which each of the sphericalsegments can be inflated. The smaller diameter cylindrical segmentsmaintain a lower profile for the torus balloon in both its deliveryconfiguration as well as during inflation and as the balloon isimplanted. In one embodiment positioning for the cylindrical segments onthe outside surface of the stent frame provides the stent-valve with anadvantage by not pushing the stent frame further away from the mitralannulus as the torus balloon is inflated. In another embodiment with thecylindrical segments positioned on the inside of the stent frame agreater area for blood flow through the central lumen of the torusballoon will be provided.

Heart valves formed from biological tissues have been used forreplacement of native heart valves in the aortic, mitral, pulmonary, andtricuspid positions. Such replacement valve have been used in surgicalprocedures and have recently been modified for use in TAVR and othertranscatheter heart valve procedures. The surgical replacement heartvalves typically have an attachment ring that is sewn or otherwiseattached to the annulus of the native heart valve tissue. Thereplacement leaflets are attached to two or three posts that extenddownstream from the attachment ring. For TAVR and other transcatheterreplacement valves, the leaflets are attached to the stent frame andfollow a crown-shaped attachment of the leaflets to the stent frame. Thetranscatheter stent frame is covered by an impervious covering that doesnot allow blood flow to pass across the wall of the stent frame suchthat the replacement heart valve can provide unidirectional flow ofblood from the upstream side to the downstream side of the stent-valveand prevention of perivalvular leakage of blood between the stent-valveand the native valve tissues surrounding the stent-valve.

Locating a covered transcatheter stent-valve upstream of the annulus ofthe native heart valve can lead to formation of a stagnation regionbetween the stent valve and the surrounding native tissue that forms thenative channel or lumen for blood flow. The presence of a covering onthe stent-valve frame can prevent blood from forming a linearhemodynamic path from the lumen of the native blood vessel or chamber ina direction downstream and into the stent-valve. This nonlinear path canresult in the formation of a stagnation region between the nativechamber wall and the covered stent-valve leading to thrombosis and theformation of thromboemboli that can be detrimental to the patient. If aportion of the stent-valve extends downstream of the securement and sealof the stent-valve to the annulus of the native heart valve it isimportant to ensure that antegrade blood flow into the stent-valve fromthe left atrium (LA) is maximized during diastolic heart relaxation, andthat stagnation of blood between the native leaflets and the stent-valveframe in the left ventricle (LV) has been minimized. Also it isimportant to ensure that during the initiation of systolic LV heartcontraction that blood can flow momentarily in a retrograde direction toassist in closing the replacement leaflets and prevent stagnation ofblood between the native leaflets and the stent-valve frame. Thestent-valve frame should be positioned across the valve annulus suchthat the potential for native valve leaflet prolapse cannot allow forentry or overhang of the native leaflet into the downstream end of thestent-valve and interfering with stent-valve function.

The stent-valve of the present invention extends in an axial directionfor a distance below (i.e., toward the LV) the annulus to prevent nativeleaflet overhang into the stent-valve but does not extend to an axialdistance that results in LVOT obstruction. The stent-valve also extendsinto the LA, but provides for blood flow from the LA to the LV withoutregions of blood stagnation. The present invention is a stent-valve thatallows for direct blood flow from the blood vessel lumen or chamber in adirection downstream from the LA and into the stent-valve withoutcausing regions of potential blood stagnation in the left atrium (LA);the stent valve also allows for blood flow between the native leafletsand the stent-valve frame in the LV to prevent blood stagnation,thrombosis, and formation of thromboemboli.

During delivery of the first component of a two component mitral valvesystem, the barbs that attach or hold the first component to the mitralannulus or mitral surrounding tissue are activated by an activatingtorus balloon. The torus balloon causes hinge regions of the barbs tobecome plastically deformed such that the barb assumes an activatedconfiguration with the barb tip extending into the surrounding mitraltissues located outside of the first component frame. Followingactivation of the barbs the first component is held adjacent to themitral tissue via the SE stent frame and is unable to migrate toward theLA or the LV due to the extension of the barb tips into the mitralsurrounding tissues.

During delivery of the first component to the mitral annulus and afterrelease of the first component from the delivery sheath, the firstcomponent is held by either control fibers or recapture struts thatextend into the delivery sheath. The first component can be fullyretracted into the delivery sheath even after the first component hasbeen allowed to expand via SE expansion energy into contact with themitral annulus. The first component can also be held via the controlfibers or recapture struts even after the activating torus balloon hasbeen inflated to activate the barbs in a radially outward direction intothe mitral annulus or surrounding mitral tissues.

In one embodiment, the first component has a second torus balloon ordeactivating torus balloon is located along the perimeter of thestent-valve frame between the stent-valve frame and the barb strut.Following the deflation of the activating torus balloon, thedeactivating balloon can be inflated if necessary to cause the barb tobecome deactivated by moving the barb tips radially inward such thatthey no longer extend into the surrounding mitral tissues. The firstcomponent can then be fully retracted into the delivery sheath or can berepositioned as required by the physician to an alternate locationadjacent to the mitral surrounding tissues.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a single member heart valve in anexpanded configuration positioned across the native mitral valveannulus.

FIG. 1B is a perspective view of the frame of a single member valve witha frustum-shaped housing.

FIG. 1C is a perspective view of a frame having a housing with a shapeof a hyperboloid of revolution.

FIG. 1D is a perspective view of a frame having a curved or concavewaist.

FIG. 1E is a perspective view of a dual component stent valve having afirst component or support frame located against the annulus and asecond component or valve frame positioned within the first component.

FIG. 2A is a perspective view of frame for a single member heart valveor a frame for a first component having two limiting cables locatedalong a perimeter of the waist and the frustum housing.

FIG. 2B is a perspective view of the frame showing the upper bulb in aperspective view.

FIG. 3A is a plan view of the waist region of a frame having barbsattached via ferrules to the frame.

FIG. 3B is a plan view of a stent valve in a smaller diameterconfiguration positioned within a delivery catheter.

FIG. 3C is a perspective view of the waist and upper bulb of a framehaving barbs attached and found in an inactive configuration with barbtips on the inside of the frame.

FIG. 3D is a perspective view of the waist and upper bulb of a framehaving barbs attached and found in an active configuration with barbtips on the outside of the frame.

FIG. 4A is a perspective view of a single member frame havingreplacement leaflets attached within a frustum shaped housing and havinga waist located adjacent to the native valve annulus.

FIG. 4B is a perspective view of a single member frame havingreplacement leaflets attached within a portion of the frustum-shapedhousing and a curved or concave waist located adjacent to the nativevalve annulus.

FIG. 4C is a perspective view of a single member frame havingreplacement leaflets attached within a frustum shaped housing and withinthe cylindrically-shaped waist located adjacent to the native valveannulus.

FIG. 5A is a perspective view of frustum shaped leaflets having a freeedge perimeter that is smaller than the leaflet base perimeter locatedat the nadirs of the leaflets.

FIG. 5B is a plan view of frustum-shaped leaflets that have been splayedout onto a flat surface showing a smaller free edge perimeter than theleaflet base perimeter.

FIG. 6A is a plan view of the cross-section of the housing top viewingthe leaflet free edges in an open configuration and having a spacingbetween the leaflet free edges and the housing top of the frame.

FIG. 6B is a plan view of the cross-section of the housing top viewingthe leaflet free edges in a closed configuration.

FIG. 7A is a perspective view of single member stent valve having acovering over a portion of the housing and providing an open area forblood flow through the open frame housing during diastole.

FIG. 7B is a perspective view of single member stent valve having acovering over a portion of the housing and providing an open area forblood flow through the spacing between the frame and the free edges andthrough the open frame housing during systole.

FIG. 7C is a perspective view of single member stent valve having acovering over the entire housing and providing an open area for bloodflow through the spacing between the frame and the free edges duringsystole.

FIG. 7D is a plan view of the single member stent valve identifying thesurfaces of the replacement leaflets and the native valve leaflets andflow features of the present design intended to prevent thromboembolifrom forming.

FIG. 8A is a perspective view of a waist region of a frame having barbsattached along a perimeter of the frame and a torus balloon attachedalong a perimeter of the frame, the torus balloon is not inflated andthe barbs are not activated and hence are on the inside or luminal sideof the frame.

FIG. 8B shows a perspective side view of two frame stent struts and theattachment of the balloon to the frame and attachment of the barb strutsto the frame via ferrules; the torus balloon is not inflated.

FIG. 8C shows a perspective side view of two frame stent struts and theattachment of the balloon to the frame and attachment of the barb strutsto the frame via ferrules; the torus balloon is inflated and the barbtips extend to the outside of the frame.

FIG. 8D shows a perspective frontal view of two frame stent struts andthe attachment of the balloon to the frame and attachment of the barbstruts to the frame via ferrules.

FIG. 9A is a top plan view of the torus balloon attached to the framewith barb struts located to the outside of the outer torus balloonperimeter.

FIG. 9B is a perspective view of the torus balloon showing the balloondiameters and perimeter.

FIG. 9C is a top plan view of the torus balloon in an inflatedconfiguration showing the barb tips extending to the outside of theframe perimeter.

FIG. 9D is a perspective view of the torus balloon showing the inner andouter diameters and showing the balloon ports for inflation.

FIG. 10A is a sectional plan view through the waist showing a torusballoon in a deflated configuration located adjacent to the barb strutsand contained within a pocket of a balloon holder that is attached tothe frame.

FIG. 10B is a sectional plan view through the waist showing a torusballoon in an inflated configuration located adjacent to the barb strutsand the barb tips being activated to extend outside of the frame.

FIG. 10C is a plan view of a torus balloon attached to stent struts ofthe frame waist.

FIG. 11A is a perspective view of a torus balloon that weaves on theoutside of two stent frame struts and on the inside of the barb strutsas a portion of the drawing of FIG. 11A.

FIG. 11B is a plan view from the top of a frame waist showing the torusballoon extending on the outside of the frame struts and on the insideof the barb struts.

FIG. 11C is a plan view from the top showing the torus balloon weavingto the outside of the frame struts and inside of the barb struts; theballoon is inflated and the barb tips extend to the outside of theframe.

FIG. 12A is a sectional view of a frame waist having a backing armattached to the frame and supporting the torus balloon on the insideperimeter of the torus balloon.

FIG. 12B is a perspective view of the frame waist having a backing armlocated on the inside perimeter of the torus balloon; the torus balloonis inflated and activates the barb strut moving the barb tip to theframe outside.

FIG. 12C is a perspective view of the torus balloon being removed fromits releasable attachment to the frame following inflation of the torusballoon, activation of the barb tips, and deflation of the torusballoon.

FIG. 12D is a sectional view of the frame waist showing a torus balloonin contact with a barb strut; the torus balloon is supported opposite tothe barb strut by a backing fiber that is attached to the frame.

FIG. 13A is a perspective view of the delivery catheter, the pushermember, and the connection of the control shaft with the balloon port.

FIG. 13B is a plan view of a connection of the control shaft with theballoon port of the torus balloon using a locking intrusion.

FIG. 13C is a cross-sectional view of the connection of the controlshaft with the balloon port having a locking intrusion.

FIG. 14 is a plan view of a threaded connection of the control shaftwith the balloon port.

FIG. 15 is a perspective view of a torus balloon having a segmentedspherical segment that makes contact with the barb strut.

FIG. 16 is a sectional view from the top of the waist region showing thesegmented torus balloon moving the barb tips to the outside of the frameduring inflation of the torus balloon.

FIG. 17 is a plan view of a segmented torus balloon and a ballooninflation port.

FIG. 18 is a perspective view of a single member stent valve having atorus balloon in a deflated configuration along the perimeter of theframe waist and located adjacent to the barb struts.

FIG. 19 is a perspective view of a single member stent valve having atorus balloon located along the perimeter of the upper bulb and locatedadjacent to the barb struts.

FIG. 20A is a plan view of a first component or support frame locatedadjacent the native valve annulus having the barbs activated by a torusballoon and extending into the annulus; a limiting cable limits furtherexpansion of the frame.

FIG. 20B is a plan view of a first component or support frame locatedadjacent the native valve annulus having the barbs activated by a torusballoon and extending into the base of the native valve leaflets.

FIG. 20C is a perspective view of a barb tip having a flattened shape.

FIG. 21A is a sectional view of a first component or support frame witha backing member and having a torus balloon in a deflated configurationand barb tips inside of the frame.

FIG. 21B is a sectional view of a first component or support frame witha backing member and having a torus balloon in an inflated configurationand barb tips outside of the frame.

FIG. 22A is a sectional view of a first component or support framehaving self-expanding barb struts held in an inactive configuration by abarb control fiber.

FIG. 22B is a sectional view of a first component or support framehaving self-expanding barb struts that have been release by a controlfiber and are in an active configuration with the barb tips outside theframe.

FIG. 23A is a perspective view of a frame waist for a first component orsupport frame having a limiting cable to limit the perimeter of thewaist from further expansion.

FIG. 23B is a perspective view of a frame waist of a first componenthaving a concave region that forms a geometrical shape that can be usedas a locking member for locking onto a second component or valve frame;the concave region also assists in providing a geometrical shape thatfits the shape of the native valve annulus and holds onto the nativevalve annulus.

FIG. 24A is a plan view of a second component stent valve or valve framethat contains replacement leaflets.

FIG. 24B is a plan view of a second component stent valve or valve framethat contains replacement leaflets; an upper bulb attached at the inletend assists in axial placement of the second component and assists inproviding a seal with a first component to prevent blood leakage betweencomponents.

FIG. 24C is a plan view of a second component or valve frame containingreplacement leaflets; the valve frame has a frustum shaped housing thathouses the replacement leaflets.

FIG. 24D is a sectional view of a dual member stent valve having asupport frame having a concave waist and a valve frame located in theinside lumen of the support frame; the valve frame also having a concavewaist that locks geometrically with the concave waist of the supportframe.

FIG. 24E is a sectional view of a dual member stent valve having a firstcomponent or support frame located adjacent to the annulus and havingbarb tips activated by a torus balloon; the support frame has a concavewaist region; the valve frame containing replacement leaflets form thesecond component and is positioned on the inside of the support frameand has a concave waist that locks with the concave waist of the supportframe.

FIG. 25 is a sectional view of a balloon expandable second componentplaced within the open central lumen of a first component or supportframe; a cylindrical dilation balloon expands the second component intocontact with the support frame.

FIG. 26A is a sectional view of self-expanding second component beingplaced within the open central lumen of a first component or supportframe; recapture struts are still attached to the valve frame of thesecond component.

FIG. 26B is a sectional view of self-expanding second component that hasbeen placed within the open central lumen of a first component orsupport frame and had its recapture struts released.

FIG. 27A is a perspective view of the semi lunar leaflets showing thecrown-shaped attachment to the wall structure of the frame.

FIG. 27B is a plan view of valve leaflets showing pockets that arecreated as the leaflets form leaflet coaptation.

FIG. 27C is a plan view of valve leaflets splayed out showing thecrown-shaped attached edge.

FIG. 28A is a plan view of valve leaflets showing the presence of axialand circumferential fibers attached to the leaflet surface to providestrength, control the leaflet compliance, and provide fibers to attachthe leaflets to the frame.

FIG. 28B is a sectional view through the thickness of a leaflet showinga fiber embedded within a polymer film.

FIG. 28C is a sectional view through the thickness of a leaflet showinga fiber embedded or sandwiched between two polymer films.

FIG. 28D is a perspective view of semilunar leaflets formed with axialfibers and circumferential fibers being attached to a frame of a stentvalve.

FIG. 29A is a plan view of a valve leaflets showing the presence ofaxial and circumferential fibers that extend within or are attached tothe leaflets and have fiber extensions that allow attachment to theframe of the stent valve.

FIG. 29B is a perspective view of valve leaflets being attached to aframe via fiber extension that are embedded or attached to the leaflets.

FIG. 30 is a plan view of valve leaflets having a thin film of a metalembedded within or attached to the surface of the leaflets to providestrength, compliance control, and a means for attachment.

FIG. 31A is a perspective view of a mitral valve used for surgicalreplacement with the leaflets in a closed configuration.

FIG. 31B is a sectional view of the replacement mitral valve showing theleaflets and leaflet free edges in a closed configuration.

FIG. 31C is a perspective view of a mitral valve used for surgicalreplacement with the leaflets in an open configuration.

FIG. 31D is a sectional view of a transcatheter mitral valve replacement(TMVR) device showing the leaflets and leaflet free edges in an openconfiguration.

FIG. 32A is a perspective view of a prior art transcatheter mitral valvereplacement (TMVR) device with leaflets in a closed configuration.

FIG. 32B is a perspective view of a prior art TMVR device with leafletsin an open configuration.

FIG. 32C is a perspective view of a prior art TMVR device that ispositioned in the left atrium above the mitral annulus with regions ofblood stagnation and thrombus formation.

FIG. 32D is a perspective view of a prior art TMVR device that ispositioned in both the left atrium and the left ventricle straddling themitral annulus and having regions of blood stagnation and potentialthrombo emboli formation.

FIG. 33A is a perspective view of a cylindrically shaped stent-valveframe component of a two-component system with leaflets in a closedconfiguration and forming a leaflet pocket.

FIG. 33B is a sectional view of a stent-valve frame component showingthe leaflets in a closed configuration.

FIG. 33C is a perspective view of a cylindrically shaped stent-valveframe component showing leaflets in an open configuration.

FIG. 33D is a perspective view of a frustum-shaped stent-valve framecomponent with the small diameter at the downstream end.

FIG. 33E is a perspective view of a frustum-shaped stent-valve framecomponent with the small diameter at the upstream end.

FIG. 33F is a perspective view of a dual member stent valve having asecond component stent-valve frame having an hour-glass shape.

FIG. 33G shows three mitral valve leaflets and their commissures.

FIG. 33H is a perspective view of a dual member stent valve showing thefirst component locking to the second stent-valve component via convexlocking regions.

FIG. 33J is a perspective view of a dual member stent valve showing thefirst component locking to the second stent-valve component via concavelocking regions.

FIG. 34A is a perspective view of a stent-valve frame mounted below theannular plane either attached to the annulus or attached to firstcomponent frame; an open stent-valve frame surface is located radiallyadjacent to the replacement leaflets.

FIG. 34B is a perspective view of a stent-valve frame mounted above theannular plane either attached to the annulus or attached to firstcomponent frame; an open stent-valve frame surface is located radiallyadjacent to the spacing between neighboring leaflets.

FIG. 34C is a perspective view of a stent-valve frame mounted such thatit straddles the annular plane; the stent-valve frame surface has opensurface both above and below the annular plane to reduce bloodstagnation and thrombus formation.

FIG. 34D shows a dual member stent-valve system having the firstcomponent located above the annulus and having the second stent-valvecomponent straddling the annulus and locking to the first component.

FIG. 34E shows a dual member stent-valve system having the secondstent-valve component primarily above the annulus but having somestent-valve component frame below the annulus to prevent native leafletoverhang.

FIG. 34F shows a dual member stent-valve system having the secondstent-valve component located above the annulus and locking to the firstcomponent.

FIG. 34G is a perspective view of the second component stent-valvehaving a second component concave region located downstream of thecommissures such that the replacement leaflets are located entirelywithin the left atrium.

FIG. 34H is a perspective view of the second component having adownstream frame component located downstream of the securement band.

FIG. 35A is a perspective view of a stent-valve component located abovethe annular plane and positioned into the left atrium; the stent-valvecomponent having a securement band that attaches to the annular plane.

FIG. 35B is a perspective view of a stent-valve component locatedstraddling the annular plane and positioned into both the left atriumand left ventricle; the stent-valve component having a securement bandthat attaches to the annular plane.

FIG. 36A is a perspective view of a second component frame positionedabove the annular plane and showing one-way valvular function of thereplacement leaflets during systole.

FIG. 36B is a perspective view of a second component frame positionedabove the annular plane and showing open stent-valve frame surfaceproviding for blood flow across the stent-valve frame surface duringdiastole.

FIG. 37A is a perspective view of a stent-valve frame that straddles theannular plane providing washing of the outside surface of the nativeleaflet surface below the annular plane during the initiation ofsystole.

FIG. 37B is a perspective view of a stent-valve frame that straddles theannular plane providing washing of the inside surface of the nativeleaflet surface below the annular plane during diastole.

FIG. 38A is a plan view of the first component of a dual member system;the first component is being positioned adjacent to the mitral annuluswhile being held by control fibers and recapture struts that are held bythe delivery sheath.

FIG. 38B is a plan view of a first component frame placed above thenative leaflets and having the barbs in an activated configuration.

FIG. 39A is a perspective view of a second component stent-valve framehaving an hour-glass shape with a waist that is narrower than anupstream portion and a downstream portion.

FIG. 39B is a perspective view of a dual member stent-valve systemhaving a first component attached to the annulus and having a secondstent-valve component positioned such that it straddles the annulus andstraddles the first component.

FIG. 39C is a plan view of a dual member stent-valve with the secondcomponent forming a geometrical fit with the first component via aconical shape that aligns and axial positions the two componentsrelative to each other.

FIG. 40 is a perspective view of a dual member stent-valve system havinga first component attached to the annulus and having a secondstent-valve component positioned above the mitral annulus and primarilyabove the first component.

FIG. 41A is a perspective view of a dual member stent-valve having asecond stent-valve component with an upper bulb and a lower bulb thatlocks above and below the first component and holds the second componentsuch that it straddles the mitral annulus.

FIG. 41B is a perspective view of a dual member stent-valve having asecond stent-valve component with an upper bulb and a lower bulb thatlocks above and below the first component and holds the second componentabove the mitral annulus.

FIG. 42A is a plan view of the first component attached to the mitralannulus via barbs that have been activated by a torus balloon.

FIG. 42B is a plan view of the first component positioned adjacent tothe mitral annulus prior to activation of barbs by a torus balloon; alimiting cable that is contiguous with the stent-valve frame restrictsfurther expansion of the first component frame.

FIG. 43A is a plan view of the first component positioned adjacent tothe mitral annulus and extending to a smaller diameter than the mitralannulus at the distal end of the first component frame due to thelimiting cable.

FIG. 43B is a plan view of the first component adjacent to the mitralannulus and having barb tips activated via a torus balloon into thesurrounding mitral tissues.

FIG. 44A is a plan view of the first component having both an activatingtorus balloon and a deactivating torus balloon; the barbs have not yetbeen activated.

FIG. 44B is a plan view of the first component having both an activatingtorus balloon and a deactivating torus balloon; the barbs have beenactivated into the surrounding annular tissues by the activating torusballoon.

FIG. 44C is a plan view of the first component having both an activatingtorus balloon and a deactivating torus balloon; the barbs have beendeactivated by the deactivating torus balloon.

FIG. 45 is a perspective view of a first component frame having a suprasecurement locking feature and an infra securement locking feature thatcan lock onto an annular plane or onto a first component frame.

FIG. 46A is a perspective view of a dual member stent-valve systemhaving a first component frame with a supra securement locking featureand an infra securement locking feature that locks onto the firstcomponent frame; the first component is still being held by the controlfibers and recapture struts.

FIG. 46B is a perspective view of a dual member stent-valve systemhaving a first component frame with a supra securement locking featureand an infra securement locking feature that locks onto the firstcomponent frame and has been released from the delivery catheter.

FIG. 46C is a plan view of a second stent-valve component frame havingframe extensions along all or a portion of its perimeter.

FIG. 46D shows a plan view of a second component having frame extensionsbeing locked into a first component to form a dual member stent-valvesystem.

FIG. 47A is a perspective view of a second component stent-valve framehaving a concave region that is able to lock with a concave region of afirst component or lock around a native valve annulus.

FIG. 47B is a plan dual member stent-valve system having a secondcomponent stent-valve frame with a concave region that is locked onto asmaller diameter region of the first component created by a limitingcable; the second component is being held by the delivery catheter.

FIG. 47C is a perspective view of a dual member stent-valve systemhaving a second component stent-valve frame with a concave region thatis locked onto a smaller diameter region of the first component createdby a limiting cable; the second component has been released from thedelivery catheter.

FIG. 47D is a plan view of the dual member stent-valve having a secondcomponent with a concave region that forms a locking attachment aroundthe limiting cable of the first component.

FIG. 47E is a perspective view of the second component stent-valveshowing the stent frame structure and showing the recapture struts.

FIG. 48 is a sectional view of a first component having two rows ofbarbs, each row being activated by a separate torus balloon.

FIG. 49A is a sectional view of a heart showing a flail leaflet thatextends toward the left atrium.

FIG. 49B is a plan view of a first component frame used without thesecond component to treat flail leaflet.

FIG. 50A is a perspective view of a hinge and strut structure that canbe used to form the first component frame or the second stent-valveframe.

FIG. 50B is a perspective view of the hinge and struts structure of FIG.50A applied to the first component frame or the second component framestructure in a unexpanded configuration during delivery within thedelivery catheter.

FIG. 50C is a perspective view of the hinge and struts structure of FIG.50A applied to the first component frame or the second component framestructure in an expanded configuration after release from a deliverycatheter.

FIG. 51A is a plan view of first component frame that conforms to anoval heart annulus and a round second component positioned within thelumen of the first component downstream of the annulus.

FIG. 51B is a plan view of first component frame that forms an ovalheart annulus into a round cross section and a round second componentpositioned within the lumen of the first component downstream of theannulus.

FIG. 51C is a plan view of first component frame that conforms to anoval heart annulus.

FIG. 51D is a plan view of first component frame that conforms to anoval heart annulus and a round second component positioned within thelumen of the first component at the annulus and forming the firstcomponent into a round cross-sectional shape.

FIG. 51E is a plan view of first component frame that conforms to anoval heart annulus and a round second component positioned at theannulus with a round cross-sectional diameter equal to the minor axis ofthe first component.

DETAILED DESCRIPTION

One embodiment of the present invention comprises a single memberstent-valve that is intended as a transcatheter replacement valve for avalve of the heart; the single member stent-valve (5) is intended to bedelivered within the lumen of the native heart valve and expandedoutwards forming a functioning valve device having replacement leaflets.The valve device will be described in an application for its use as atranscatheter mitral valve replacement (TMVR) although it is understoodthat the invention can be applied to other valves found within theheart. The invention further comprises a dual member stent valvecomprised of two components, a first component or support member and asecond component or valve member. The first component is deliveredacross the annulus of the heart and affixed to the annulus or othernative tissues of the heart; the first component does not interfere withfunction of native valve leaflets such that the mitral valve is fullyfunctional while awaiting the delivery and implant of a secondcomponent. The first component does not itself contain any replacementleaflets, and has an open lumen that allows unimpeded blood flow in boththe upstream and downstream direction such that it can be positionedaccurately across the mitral annulus without hemodynamic forces imposedon the first component. The second component or stent-valve component orvalve member of the dual member stent-valve is delivered subsequent tothe first component and is placed within the open central lumen of theexpanded first component; the second component contains the replacementleaflets that control blood flow in an antegrade or downstream directionfrom the left atrium (LA) to the left ventricle (LV). In describingvarious embodiments of the invention, it is understood that the singlemember stent-valve can have a fixation elements or barbs that functionto hold or attach the frame of the single member stent-valve against theannulus tissues of the native heart valve to prevent migration of theframe; the same fixation elements can be found in the first component ofa dual member stent-valve. Additionally, it is understood that thereplacement valve leaflets found in the single member stent-valve areattached to the stent frame to direct blood flow in a downstreamdirection; the leaflets can be attached to the stent frame of the secondcomponent of the dual member stent-valve in the same manner as thatfound in the single member stent-valve.

The first component or support member of the dual member stent-valveprovides, in itself an invention that functions as an adapter that canbe implanted within the tissues of a native heart valve. Followingimplantation of the first component or adapter, a second device such asa stent-valve already available on the market can be implanted into theopen central lumen of the first component. The second component can be,for example, a balloon expandable (BE) stent-valve or a self-expanding(SE) stent-valve used for transcatheter aortic valve replacement (TAVR)or other similarly sized stent valve device application. Alternately,the second component can comprise one of the embodiments of the secondcomponent that are presented in the present application. The referencenumerals and reference names from each embodiment of this specificationcan be applied to other embodiments bearing the same reference numeralsor reference names found in this specification.

One embodiment for the frame of the single member stent-valve (5) of thepresent invention is shown in FIGS. 1A-1D; the waist (10) of the frame(15) or stent-valve frame (15) of the single member stent-valve (5) canbe implanted adjacent to the annulus (20) of the native mitral valve asshown in FIG. 1A. The waist (10) of the single member stent-valve (5)can have barbs (25) located along the waist perimeter (30) as shown inFIG. 1A and further described in other embodiments of the invention; thebarbs (25) can be activated by dilation of a torus balloon (35). Theframe (5) of the single member stent-valve (5) holds the replacementleaflets; the frame (15) is formed from an elastically deformablematerial such as Nitinol, Elgiloy, or other elastic, metal, plastic, orcomposite material. The wall structure of the portions of the frame (15)can be an open cell zig-zag structure, a closed cell structure, acombination of open and closed cell or any other wall structure geometrythat has been used or proposed for use in stents or stent-valves forvascular therapy.

The frame (15) is comprised of a cylindrical stent or a curved stentthat forms the waist (10) of the present embodiment; the waist (10) islocated adjacent to the valve annulus (20) (20) such as the mitral valveannulus (20). The waist (10) can have a non-cylindrical or curved shapethat forms a curved waist (40) along its perimeter that is in contactwith the native valve annulus (20) as shown in FIG. 1D and extends witha concave region (42) radially inward toward the central axis (45) ofthe frame. For the curved waist (40) the waist central diameter (50) hasa smaller diameter than either the waist inlet diameter (55) or thewaist outlet diameter (60). The waist central diameter (50) is 5 mmsmaller (range 2-10 mm smaller) than the waist inlet diameter (55) orwaist outlet diameter (60). The waist (10) is formed with a storedenergy that exerts a frame outward force (65) onto an average sizedannulus (20) of 35 mm diameter (range 25-48 mm) that is equivalent tothe force provided by a 5 atm balloon (range 4-7 atm) of the samediameter. The large outward force of the waist (10) pushes the waist(10) into the mitral annulus (20) and forms a seal between the waist(10) and the mitral annulus (20). The waist (10) is attached to orcontiguous with the upper bulb (70) which extends outwards from itsattachment to the waist; the upper bulb (70) extending into the LA (80)with an upper bulb inlet diameter (75) that is larger than the waistinlet diameter (55). The upper bulb (70) extends outwards with an upperbulb angle (85) that can be at a 90 degree angle with respect to thewaist (10) axial direction (90) or at a 45 degree angle or at anintermediate upper bulb angle. The upper bulb (70) serves to provide animproved seal between the upper bulb (70) and the annulus (20) and wallof the LA (80) as the upper bulb (70) undergoes healing with the mitralannulus (20) and surrounding tissues will serve to hold the mitralannulus (20) from further dilation; also, the upper bulb (70) serves tolocate the waist (10) such that it is positioned adjacent to the annulus(20). Attached to or contiguous with the upper bulb (70) and extendingupstream (95) into the left atrium (LA) are recapture struts (100);these struts are somewhat weaker in outward force than the waist outwardforce and have a larger overall equilibrium diameter and shape thatmatches the larger and curved or rounded surface found in the leftatrium (LA). The recapture struts (100) allow the waist (10) and frame(15) of the present invention to be released from a delivery sheath(105) and placed into contact with the mitral annulus (20) andrecaptured back into the delivery sheath (105) if the position of thewaist (10) with respect to the mitral valve annulus (20) is not inposition along the length of the axial direction (90) of the frame. Therecapture struts (100) can be retained within a delivery sheath (105),for example, while the stent waist (10) has been released into contactwith the mitral annulus (20). The frame (15) can be repositioned, ifnecessary, a second time across the mitral annulus (20). A holdingfeature (110) located at the proximal end (115) of the frame (15) allowsthe recapture struts (100) to be held by one or more control fibers(120) that extends through the delivery sheath (105) to a locationoutside of the body. A pusher member (122) is used to push the stentvalve frame (15) out of the delivery sheath (105).

Attached to or contiguous with the distal or waist outlet end (125)(toward the distal end of the waist) is the housing (130). The housing(130) has the shape of a conical surface having its tip cut off at itstop forming a frustum and provides a housing in one embodiment forreplacement leaflets (270) which will serve to direct antegrade bloodflow downstream from the LA to the LV and restrict retrograde blood flowfrom the LV to the LA. The larger housing base (135) of the frustum isattached to the waist, and the housing top (140) of the frustum-shapedhousing (130) is located at the housing outlet end (145). Alternately,the housing (130) can have the shape of a one-sheeted hyperboloid ofrevolution that has been truncated as shown in FIG. 1C; the base of thehyperboloid is located adjacent to and attached to the waist (10) andthe truncated portion that forms the top of the hyperboloid is locatedat the outlet end or outflow end of the housing (130). Both the frustumand the truncated hyperboloid are shapes that get continuously larger indiameter as they extend along their axial direction (90) from thehousing top (140) to the housing base (135) of the frustum-shapedhousing (130); the housing (130) for this embodiment does not contain acylindrical region.

With the frame (15) implanted across the mitral annulus (20) as shown inFIGS. 1A and 1B the frustum-like shaped housing (130) (including thehyperbolic-shaped housing (130)) does not impinge upon the nativeanterior mitral leaflet (150); the left ventricular outflow tract (LVOT)(155) is not restricted from flow of blood out of the aortic valve (160)due to systolic contractions of the left ventricle, LV (165). As shownin FIG. 1B, the native anterior mitral leaflet and native posteriormitral leaflet (170) are able to approximate the housing outer surface(175) and prevent the formation of a low blood flow region that would besusceptible for formation of thrombus or thromboemboli that could leadto the formation of a stroke. The native free edges (176) of the nativeanterior mitral leaflet (150) and native posterior mitral leaflet (170)are attached via cordae tendineae (177) to papillary muscles (178) toprevent leaflet eversion during the cardiac systolic cycle. The housingbase (135) of the frustum-like housing (130) is expanded outward to aperimeter that is equal to the perimeter of the mitral annulus (20); theeffective diameter of the mitral annulus (20) (i.e., diameter of acircle have a specified perimeter) is an average of 35 mm (range of25-48 mm); the housing top (140) of the frustum-like housing (130) has ahousing top perimeter (180) and housing top diameter (182) that is 30%smaller (range 25-35% smaller) than the housing base perimeter (183) andhousing base diameter (184) of the housing base (135) in its expandedconfiguration; the diameter of the top of the frustum is 25 mm (range18-30 mm). The housing length (185) of the frustum-like housing (130)from the housing top (140) to the housing base (135) is 20 mm (range10-30 mm).

The stent-valve frame (15) as described in FIGS. 1A-1D can also be usedas an embodiment for a second component (190) of a dual member stentvalve (195) as shown in FIG. 1E. The second component (190) can have avalve frame (192) similar to the stent frame (15) structure as describedfor the single component stent-valve; the second component (190) isdelivered into the open central lumen (265) of the first component orsupport frame (200). The second component waist (205) would, however, bedelivered adjacent the first component waist (210) as shown in FIG. 1E;the first component waist (210) would be located adjacent and in contactwith the native valve annulus (20). Also, the second component (190) maynot contain the barbs (25) as described for the single componentstent-valve; the) would contain barbs (25) for fixation of the dualmember stent-valve as described in other embodiments of this patentapplication.

FIGS. 2A and 2B show a side and perspective view of waist, upper bulb(70) and housing (130) of the frame (15) comprising the single memberstent-valve (5) or the second component (190) of the dual member stentvalve (195) of the present invention; replacement leaflets would beattached to the frame as described in other embodiments. The upper bulb(70) extends from the waist inlet end (215) with a bulb angle (85) of 45degrees off of the axial direction (90) (range 20-90 degrees). Thehousing base (135) is attached to the waist outlet end (125); thehousing (130) extends in a distal direction (218) toward the housing top(140) with a housing angle (220) (measured with respect to the axialdirection (90)) of 11 degrees for a frustum (range 6 to 22 degrees); thehousing angle (220) is 30 degrees (range 10-45 degrees) for ahyperboloid-shaped housing (130). A limiting cable (225) can be attachedto the stent frame (15) or can be contiguous with the stent frame (15)along the waist perimeter (30) to limit the amount of radial expansionthat the waist (10) is allowed to extend; the limiting cable (225) canalso be attached along a perimeter of the housing (130). The cable canbe formed from multifilament materials such as stainless steel,polyethylene terephthalate, Nitinol, and other polymer or metalmaterials, alloys, or composites. The cable is very soft in its abilityto bend due to the multifilament strands of very small diameterfilaments, typically having a filament diameter of 10 microns (range 5microns to 100 microns). The cable is able to be easily folded back uponitself by application of a bending force equal to 50 grams (in earthgravitation). The limiting cable perimeter (235) is set to be 3 mmlarger (range zero to 9 mm larger) than the perimeter of the annulus(20) such that the waist (10) of the stent with it large outward forceis able to make direct contact around the perimeter of the annulus (20)without influence of the cable constraint; the cable prevents anyfurther force to be exerted against the annulus (20) once the cable hasreached its full perimeter. For a 35 mm annulus (20) effective diameter,for example, a 35-37 mm effective diameter of the cable would be usedhaving a cable perimeter that is zero to 6 mm larger than the perimeterof the annulus (20) and a cable effective diameter (i.e., diameter of acircle with the perimeter of the cable) that is zero to 2 mm larger thanthe effective diameter of the annulus (20). The housing (130) getscontinuously smaller as it extends in the axial direction (90) from thebase to the top of the housing (130).

FIGS. 3A-3D show one embodiment of the waist (10) and upper bulb (70)portions of the frame (15) that can be applied to the single memberstent-valve (5) and also to the first component (200) of the dual memberstent-valve (195). In this embodiment a balloon expandable (BE) set ofbarbs (25) are located around the waist perimeter (30). The waist (10)is constructed by interleaving a first zig-zag stent (240) with a secondzig-zag stent (245) such that first and second zig-zag stents are heldtogether by ferrules (250) placed along the frame or waist perimeter(30). The upper portions of the zig-zag stents form the upper bulb (70)and the lower portions of the zig-zag stents form the waist. Amultiplicity of barbs (25) (range 8-40) are attached to the ferrules(250) such that the barb tip (255) does not extend to the outside of acircle formed by the waist (10) when the stent frame (15) is locatedwithin the delivery sheath (105) to reach its expanded configuration asshown in FIG. 3B or after release from the delivery sheath (105) asshown in FIG. 3C. The barb strut (260) is formed from a BE material suchthat upon exposure to a dilation balloon such as a torus balloon (35) asshown in FIG. 3D (or other shaped dilation balloon), the barb is forcedoutwards into the annulus (20) via a balloon outward force (228) of thetorus balloon (35) onto the barb (25).

The frame waist (10) as shown in FIGS. 3C, 3D, 4C, and 4D can be aportion of a single member stent-valve frame (15) that containsreplacement leaflets; alternately the frame waist (10) can be a portionof the first component (200) of a dual member stent-valve (195); thefirst component (200) of the dual member stent valve (195) does notcontain replacement leaflets and serves as an adapter into which asecond component (190) that contains replacement leaflets can bepositioned and implanted into the central lumen (265) of the adapter.

The barb strut (260) of this embodiment can be formed from stainlesssteel or plastically deformable metal, polymer, or biodegradablematerial. The barb tip (255) is formed with a pointed shape that extendsin a direction perpendicular to the barb strut (260) and directed towardthe tissue of the mitral annulus (20) when it is activated to expandinto the annulus via inflation of the torus balloon (35). The barb strut(260) can have a diameter of 0.003 inches (range 0.002-0.006 inches).

The barb tip (255) can be formed from a metal, polymer, or from abiodegradable material such as polylactic acid, for example. The barbtip (255) extends outwards for a distance of 2 mm (range 1 to 4 mm) suchthat the barb tip (255) will not be able to reach outwards beyond themitral annulus (20) and extend into the circumflex artery or otherinappropriate tissue. The barb should have adequate surface area toensure that the stent frame (15) does not migrate toward the LA (80) dueto pressure and force applied by the LV (165) onto the stent frame; thebarb strut (260) can be formed with a flattened shape (see FIG. 20B),for example, to maximized the area of the barb tip (255) that isresisting the migration force imposed by the LV (165) blood pressure.The flattened barb tip (255) can have a dimension ranging from0.003-0.010 inches in each perpendicular direction forming the barb tiparea. Each structural element of the waist (10) (i.e., a zig-zag repeatsegments, for example) can contain one or more barbs (25) such that thenumber of barbs (25) along the perimeter of the waist (10) can rangefrom as few as 8 to 40 or more barbs (25). Under the condition that over40 barbs (25) are placed along the waist (10) of the present stentframe, the length of the barb tip (255) can be reduced to less than 2mm; for a smaller number of barbs (25), the barb length would extend outat length nearer the upper tip distance range. Approximately 16 barbtips (255) (range 8-40 barb tips) are positioned equally along theperimeter of the waist (10) and extend radially into the native hearttissue for a distance of 3 mm (range 2-5 mm) to hold the stent-framewaist (10) from migrating toward the LA (80) due to LV (165) pressuresof 200 mm Hg.

The barbs (25) ensure that the frame (15) of the present invention alongwith the frictional forces provided by the waist (10) and upper bulb(70) will not migrate towards the LA (80) during the systolic cycle ofthe heart and also assist in preventing migration into the LV (165)during diastole. It is understood that the barb struts (260) can beformed to be contiguous with the waist (10) portion of the frame (15) orcan be attached to the waist (10) portion of the frame (15) viaalternate attachment methods including adhesives, brazing, welding,thermal bonding, swaging, crimping with ferrules, and other attachmentmethods.

Found along the waist perimeter (30) of the single member stent-valve(5) or the first component (200) of the dual member stent-valve (195)embodiment is a limiting cable (225); additional limiting cables (210)can also be located along other perimeters of the frame. The limitingcable (225) can extend through each of the ferrules (250) that arelocated along a perimeter of the frame; the ferrules (250) can becrimped closed to prevent the stent frame struts (267) of the waist (10)portion of the stent frame (15) from extending outwards beyond aspecified preset perimeter. The limiting cable (225) is formed frommultiple filaments or other construction and construction materialsdescribed previously that are very flexible. The presence of thelimiting cable (225) allows the waist (10) portion of the frame (15) ofa single member stent-valve (5) to exert a larger (larger than astandard stent of the same diameter) frame outward force (65) prior tobeing limited by the limiting cable (225) (i.e., equal to a 6 atm (range2-20 atm) dilation balloon of 35 mm diameter) to ensure that the annulus(20) is formed into a round shape and that direct contact is madebetween the waist (10) and the annulus (20) along the entire perimetersuch that a good seal is created to prevent leakage of blood between theframe (15) and the annulus (20). For a dual member stent-valve assemblythe presence of a limiting cable (225) in the waist (10) of the supportcomponent or first component (200) that is positioned adjacent to theannulus (20) to provide a defined perimeter ring into which a secondcomponent (190) (or valve component) can be delivered to form africtional or geometric lock between the first component (200) andsecond component (190); this is further described in later embodiments.The limiting cable (225) prevents the waist (10) from continuing toexert an outward force onto the annulus (20) that can result in unwanteddilation of the annulus (20) which is often times already too large indiameter and is the cause of the mitral regurgitation that is beingaddressed by the present mitral valve replacement device. A torus shapeddilation balloon (35) (described further in later embodiments) can bedilated to generate a balloon outward force (228) to push the barb tips(255) outwards into the native mitral valve annulus (20) or adjacenttissue to fixate the stent-valve and prevent migration of thestent-valve. Backing member or backing element (450) provides thesupport for the torus balloon (35) to push against to generate theoutward force (228) to move the barb (25) outwards during ballooninflation. The dilation balloon can alternately be replaced by acylindrically shaped braided expansion member or other expansion memberthat allows blood flow to pass freely across the expansion member whilein an expanded configuration.

FIGS. 4A to 4B show the frustum-shaped or hyperboloid-shaped housing(130) (i.e., frustum-like housing (130)) attached downstream to thecylindrically-shaped waist or curved-shape waist (40) that is locatedadjacent to the annulus (20). The device as shown in FIGS. 4A-4C can bea single member stent-valve (5) that contains replacement leaflets (270)and is delivered with the frame waist (10) adjacent to the mitralannulus (20). In this embodiment three leaflets are located within thehousing (130), however, the present invention can instead include onlytwo leaflets or up to four leaflets. The leaflets are attached to thewall of the housing (130) in a crown-shaped leaflet attachment (275)having the nadirs (280) of the leaflets located at the base of thehousing (130) as shown in FIG. 4A, the nadirs can alternately be locatedbetween the housing base (135) and the housing top as shown in FIG. 4Bor can be located in the waist. The attachment of the leaflets to thehousing (130) can be via direct attachment of the leaflets to the struts(267) of the housing frame (130) or to the fabric or covering (285) thatis attached to all or part of the housing frame (130). Various forms ofattachment of the leaflets can be used including suturing, adhesives,polymer bonding, thermal bonding, and other forms of attachment. In analternate embodiment the leaflets can be attached to both the housing(130) and the waist (10) as shown in FIG. 4C where the nadirs of theleaflet attachments (275) are located at the junction (290) of the waist(10) and the upper bulb (70) such that the housing length (185)extending in an axial direction (90) from the waist (10) to upper bulbjunction (290) to the housing outlet end (145) is reduced, therebyreducing the liklihood for impingement of the housing (130) onto theanterior native mitral leaflet.

In an alternate embodiment, the device shown in FIGS. 4A-4C can be asecond member or second component (190) of a dual member stent-valve(195); the second member that contains replacement leaflets (270) wouldbe implanted within the lumen of a first member (or support member) thatis initially implanted across the mitral annulus (20) and attached tothe native heart tissue via barbs (25) as described in otherembodiments.

As shown in FIGS. 5A and 5B the leaflets themselves form a frustum-likeshape or hyperboloid-like shape that fits precisely within thefrustum-shaped or hyperboloid-shaped housing (130). Each leaflet has afree edge (295) that forms a leaflet top (300) and that resides at ornear the level of the housing top (or downstream end) of the housing(130); the leaflet free edge (295) has a smaller leaflet free edgeperimeter (305) than the housing top perimeter (180); the nadirs (150)of the leaflet attachment (275) to the housing (130) follow a leafletbase perimeter (310) that coincides with the larger housing baseperimeter (183) located at the housing base (135). The pressure forcesfrom the LV acting on the free edges (295) of the leaflets and theleaflet regions nearest the free edges (295) are lower due to thereduced area of exposure at the smaller downstream end of the frustum;the leaflets are less likely to undergo stress fracture failure. Thehousing base perimeter (183) is equal to Pi*D where D is the housingbase diameter (184); the housing top perimeter (180) is Pi*d where d isthe housing top diameter (182). FIG. 5A shows a perspective view of thefree edges (295) of the leaflets coaptation with each other to preventflow of blood during systole from the housing top toward the housingbase. Upon cutting the frustum-shaped housing (130) along one side andsplaying it open as seen in FIG. 5B, one can view the free edges (295)of the three leaflets and the crown-shaped attachment of the leaflets tothe frustum-shaped housing (130). The replacement leaflets (270) areattached to the housing top at three commissures (312); the free edges(295) of the leaflets also join to their neighboring leaflet at thecommissures (312). The replacement leaflets (270) are attached to thehousing (130) along the frustum-like shape of the housing (130) andthereby themselves have a frustum-like shape when the cut edge is closedas shown in FIG. 5A.

The replacement leaflets (270) can be formed from various types oftissues including pericardial tissue or tissues taken from a variety ofanimal sources. The tissues are often treated via a crosslinking processincluding glutaraldehyde processing, for example. Other leaflet materialinclude polymer film, ePTFE, Dacron fabric, polyethylene terephthalatefilm or fabric, polyurethane, composite materials Including Nitinolformed as a composite thin leaflet, or other thin and strong materialsthat are suitable for implant. A metal frame such as Nitinol, forexample, or alternately, fibers can be sandwiched between or containedbetween polymeric film or tissue film members to provide strength andproper flex characteristics to the replacement leaflets (270); leafletaxial strain of up to 15% is attained during the systolic portion of theheart contraction cycle in comparison to diastole; circumferentialstrain is limited to less than 10% during systole.

FIGS. 6A and 6B show an end view of the housing top (140). FIG. 6A showsthe leaflets in an open condition as found during diastole; the freeedges (295) of the leaflets do not make contact with the housing wall(320) at the housing top (140). The leaflet free edge perimeter is 10%(range 5-20%) less than the housing top perimeter (180). This perimeterdifference provides a gap or spacing (325) between the free edges (295)of the leaflets and the housing top between respective commissures (312)to allow for blood flow to the back side or LV (165) side of thereplacement leaflets (270) during systole to ensure that the leaflet isproperly cleansed by blood flow and reduce thrombus formation, and alsoprovide direct access for blood pressure to assist in closing theleaflets during systole when the native leaflets can be pushed via bloodpressure into contact with the housing (130). The leaflet free edge canbe seen to be attached to the housing top at each of the threecommissures (312). FIG. 6B shows the free edge of the leaflets at thelevel of the housing top in a closed configuration as found duringsystole. Here the free edges (295) are seen coapting or touching thefree edge of a neighboring leaflet forming a leaflet coaptation (315) toprevent blood flow from the LV (165) to the LA. In an alternateembodiment the spacing (325) can be eliminated allowing the leaflet freeedge (295) to come into direct contact with the housing top (140) orother surface of the housing (130).

FIGS. 7A-7C show the waist, the upper bulb (70), and housing (130) andthe fabric or covering (285) that is attached to all or part of thesingle member stent-valve frame. The fabric can be sewn, bonded byadhesive, or otherwise attached to the frame (15) of the waist, theupper bulb (70), or the housing (130). The fabric can be formed from anexpanded polytetrafluoroethylene (ePTFE), Dacron, a woven fabric, orother thin material that will not let blood flow across its wallthickness. As shown in FIGS. 7A and 7B the fabric is attached along theentire perimeter of the waist (10) and along the entire waist length(332) in the axial direction (90); the fabric extends at least to coverthe surface of the housing (130) extending from the housing base (135)to crown-shaped line of attachment of the leaflets to the housing (130).The fabric can also extend to cover the surface of the upper bulb (70)to assist in preventing leakage between the frame (15) and thesurrounding tissues of the annulus (20) and LA. The fabric extends toeach of the three commissures (312). The remainder of the housingsurface (175) is an open housing surface (179)(i.e., without a covering(285)) that allows radial blood flow (330) through the non-covered wallof the housing (130) through the open housing surface (179). As shown inFIG. 7A radial blood flow (330) can occur at the early start of systoleinto the outlet end of the housing and flow out of the open housingsurface (179) as systolic blood flow that will keep the outer surfaces(171) of the replacement leaflets (270) clean and free of thromboticdeposition. During diastole a diastolic blood flow of blood can occur inthe form of a recirculation pattern through the open housing surface(179); this blood flow can also help to keep the outer surfaces (171) ofthe replacement leaflets (270) clean. The native leaflets have bloodflow across their inner or central surfaces (172) from the systolicradial blood flow and from the diastolic blood flow to maintain thenative leaflets in a condition of pivotal movement at its attachment tothe mitral annulus (20) from a leaflet location adjacent the housingouter surface (175) during middle to late systole as shown in FIG. 7B toa location that is removed or separated from the housing outer surface(175) toward the lateral wall of the LV (165) during early systole andduring diastole as shown in FIG. 7A.

As shown in FIG. 7C, in an alternate embodiment the fabric or covering(285) can be attached to the entire outer surface of the housing (175).The fabric can also be attached along the waist (10) and can be attachedto the upper bulb (70). In this embodiment the native leaflets wouldtend to position themselves against the housing outer surface (175)during early systole, late systole, and during diastole since bloodcannot flow across the housing wall (320) if the housing (130) has afabric or covering (285). The inner surface (172) of the native leafletswould tend to become attached to the fabric that is located on thehousing outer surface (175). The frustum-like shape of the housing (130)allows the native leaflet to lie flat against the outer surface of thehousing (175) without restriction from the chordae tendineae. Also, noaspect of the present frame (15) pushes outward on the leaflet with aradial outward component that would limit the ability of the nativeleaflets from moving into direct apposition with the entire housingouter surface (175). The native leaflets that are in contact with thepresent housing (130) tend to become healed against the housing outersurface (175) across their entire inner surface thereby eliminating anysource for thrombus. Since the housing has a frustum-like shape, thenative leaflets can fit snugly against the housing outer surface (175)without the presence of pockets or open areas that can result inthrombus formation. Thus, the shape of the frustum or hyperboloidhousing (130) is necessary to ensure that the native leaflets canapproximate the housing outer surface (175) and not be held away fromthe housing (130) by the chordae tendineae or by any structure of thestent-valve frame (15) that can hold the native leaflet from making fullapproximation with the housing outside surface (175). The outer nativeleaflet surface (173) would remain free of thrombus due to the directaccess to blood flow during systole and the recirculation blood flow inthe LV (165) during diastole thereby preventing thrombus formation onthe outer surface of the native mitral valve leaflets.

The device of FIGS. 7A-7C and alternately describe a second component(190) (or valve member) of a dual member stent-valve (195). The secondcomponent (190) would be delivered into the open central lumen (265) ofa first component (200) that was delivered initially across the nativemitral annulus (20). The second component waist (205) of the secondcomponent (190) stent-valve frame (15) would be positioned adjacent tothe waist (10) of the first component (200) as described in subsequentembodiments.

During the method of use for the single member stent-valve (5) thedelivery sheath (105) enters the mitral annulus (20) with the waist (10)of the frame (15) located adjacent to the mitral annulus (20) and thesheath is withdrawn partially while holding the pusher member (122) in afixed position (see FIG. 1A). As the delivery sheath (105) is withdrawnthe waist (10) expands out into contact with the mitral annulus (20),the upper bulb (70) expands out into contact with the LA, and thehousing (130) is positioned across the native leaflets of the mitralvalve. The recapture struts (100) are being held by the release cordsthat are extending within the pusher tube. If the operator does notconsider that the waist (10) is properly positioned adjacent to themitral annulus (20), the stent-valve can be withdrawn back into thedelivery sheath (105) by pulling back with tension onto the pusher whilemaintaining position of the delivery sheath (105); alternately thestent-valve can be withdrawn by applying tension onto the pusher whileadvancing the delivery sheath (105) forward under compression. If theposition of the stent-valve is acceptable, the recapture struts (100)are released by the release cords such that the recapture struts (100)expand outwards with low radial force into contact with the wall of theLA. The recapture struts (100) are thinner and more flexible than thestruts (267) of the waist (10) and the upper bulb (70); their purpose isto allow the frame (15) to be withdrawn into the delivery sheath (105)and the entire frame (15) can be repositioned relative to the axialposition of the waist (10) with the annulus (20) or for improved axialalignment such that the device axial direction (90) is collinear withthe axial direction (90) of the mitral annulus (20).

As described in earlier embodiments shown in FIGS. 3B-3D balloonexpandable fixation elements such as barbs (25) can be attached to thewaist portion (i.e., the waist (10)) of the stent frame (15) (i.e., thewaist (10), the upper bulb (70), and the housing (130)) of thestent-valve of the present invention. A dilation balloon having acylindrical shape, hour-glass shape, or other shape can be used as apost dilatation tool to activate the barbs (25) comprised of a barbstrut (260) and barb tip (255) by pushing the barb tips (255) outwardsinto the tissues of the mitral annulus (20). Such a dilation balloonwould also block the blood flow across the mitral annulus (20) when itwas being inflated thereby negatively affecting blood flow output fromthe heart to critical tissues of the body including the brain.Furthermore, an inflated balloon can be pushed toward the LA (80) via LV(165) pressure during systole; interaction of the inflated balloon withthe stent frame (15) can cause the stent frame (15) to also move towardthe LA (80) placing the stent frame (15) in an incorrect position withthe waist (10) no longer positioned appropriately adjacent the mitralannulus (20). To address these concerns a torus-shaped balloon (i.e.,torus balloon (35)) is presented that activates the balloon expandablefixation elements by applying a balloon outward force (228) to pushesthe barbs (25) outwards into the tissues of the mitral annulus (20) andallows blood flow through the central regions of the torus balloon (35)during balloon inflation. The torus balloon (35) in one embodiment isinflated with saline or other similar physiological fluid or solution;the saline is provided an exit opening or balloon port that is used toinflate the torus balloon (35) and also provide a leakage path for fluidto leak out of the torus balloon (35) after the barbs have beenactivated to an outward position into the annulus or other valve tissue.The leakage path can be via the balloon port; alternately, the fluid canleak out of the balloon via migration of the fluid through the material(such as ePTFE) used to form the wall structure of the torus balloon.The torus balloon (35) of one embodiment is permanently attached to thestent frame (15) and hence is implanted along with the stent frame (15)within the heart; in other embodiments the torus balloon (35) can beremoved from the stent frame (15) after the torus balloon (35) has beeninflated to activate the barbs (25) and subsequently deflated. In stillanother embodiment the torus balloon (35) can be filled with a curablepolymer, gel, or foam and is retained within the torus balloon (35) andis not allowed to leak out of the balloon following activation of thebarbs (25).

FIGS. 8A-8D show an embodiment for the waist (10) of the stent frame(15) for a single member stent-valve (5) or for the first component(200) of a dual member stent-valve (195). The frame waist (10) isattached to the annulus (20) via barbs (25) which are activated to forcethe barbs (25) outward into the annulus (20). The waist (10) of a firstcomponent (200) is positioned upstream (95) of the native mitral valveleaflets to reduce interference with native mitral leaflet function. Thewaist (10) is shown with a torus balloon (35) attached to the waist (10)of the stent frame (15) although it is understood that the torus balloon(35) could be attached to the upper bulb (70) of the stent frame (15) orto the housing (130) of the single member stent-valve. The waist (10) inthis embodiment has a frame (15) with from an open cell wall structurebut it could equally be formed from a closed cell construction or otherwall structures found in stent and stent-valve devices. In thisembodiment the waist (10) is formed from a zig-zag structure (335)having generally straight stent struts (267) that are joined orcontiguous with bent regions (340). This embodiment is shown havingferrules (250) that are located along a perimeter at the waist inlet end(215) or upstream end and waist outlet end (125) or downstream endalthough it is understood that other stent frame (15) structures withoutferrules (250) can be used without deviating from the present invention.The ferrules (250) can be used to attach the barb strut (260) to thewaist (10) as shown in FIG. 8A; alternately the barb strut (260) can beformed contiguously with the stent struts (267) or can be attached tothe stent frame (15) via an attachment method such as welding, brazing,or via adhesives and not require the ferrules (250) as part of the stentframe. The barb struts (260) are formed from a balloon expandable (BE)material such as stainless steel or other plastically deformablematerial used in stent construction. At one end of the barb strut (260)is a barb tip (255) that is sharp and pointed outwards toward theoutside (350) of the stent frame. The barb tip (255) is 2 mm long (range1-5 mm) such that it can extend to the outside of the stent frame (15)by 2 mmm upon activation into the mitral annulus (20) to hold the stentframe (15) from migration toward the LA. The barb tip (255) can beformed into a flattened shape to enhance the area of contact with thetissue to prevent migration of the stent frame. When the barb tip (255)is inactive, it rests within the frame luminal side (345) and does notextend to the frame outside (350). Located adjacent to and in directcontact with the barb strut (260) towards the inside of the stent frame(15) is the torus balloon (35). The torus balloon (35) of thisembodiment is in direct contact with the stent struts (267) and alsowith barb struts (260). The torus balloon (35) is adjacent to theannulus (20) but does not make contact with the mitral valve leafletsurface on the side of the leaflets that is adjacent to the LV (165)wall or adjacent to the LVOT. In some embodiments the torus balloon (35)is in direct contact with the mitral annulus (20). The torus balloon(35) can be attached directly to the frame struts (267) or the ferrules(250) of the waist (10) of the stent frame (15) via adhesives, sutures,or other bonding methods. Alternately, the torus balloon (35) can beattached to the frame (15) via balloon attachment members (355) thatattach to frame attachment sites (360) located on the stent frame. Theballoon attachment members (355) are aligned with the barbs (25) in aradial direction such that the balloon attachment members (355) providea backing support to transfer the outward forces (228) of ballooninflation onto the barbs (25) to move the barbs (25) radially outwardsduring balloon inflation. The balloon attachment members (355) can beformed from polymer or metal fibers or sutures that can support tensionof 5 lbs. (range 1-10 lbs.). The balloon attachment members (355) can beattached to the torus balloon (35) at balloon attachment sites (365);balloon attachment sites (365) for joining the attachment members (355)to the torus balloon (35) can be made via adhesives, fiber attachment,and other bonding methods.

Shown in FIGS. 8B-8D are specific portions of the stent frame (15) asdescribed in FIG. 8A. In FIG. 8B stent struts (267) located at the rightside of the waist (10) in FIG. 8A are depicted along with a deflatedtorus balloon (35) located adjacent to the inside of the barb strut(260). The torus balloon (35) is attached to the stent frame (15) at thestent struts (267), the bent regions, or at the ferrules (250) viaattachment members (355). The attachment can be made via a cable or astent frame member that attaches directly to the torus balloon (35) orprovides a support that directs the torus balloon (35) inflationradially outwards into a direction that applies a radially directedballoon outward force (228) against the barb thereby advancing the barbtip (255) into the annulus (20) located outside (350) of the perimeterof the stent frame waist. Upon inflation of the balloon as shown in FIG.8C the barb strut (260) is pushed outwards placing the barb tip (255)extending outside (350) of the stent frame and into the tissue thatsurrounds the stent frame (15). A frontal view of the torus balloon (35)located behind a barb strut (260) and also behind (i.e., on the luminalside (345) of) two stent struts (267) is shown in FIG. 8D. The torusballoon (35) can be attached directly to stent struts (267); suchballoon attachment sites (365) can be formed with adhesives, polymericcoatings, and other bonding methods. The barb tip (255) faces forward(i.e., toward the observer) and will be pushed further forward as thetorus balloon (35) is inflated. Inflation of the torus balloon (35) willpush the barb tip (255) outwards to the outside (350) of the stentframe; the torus balloon (35) of this embodiment will remain on theinside of the stent frame (15) and hence will not push the stent frame(15) away from the mitral annulus (20).

FIGS. 9A and 9C show a top view of the waist (10) region of the stentframe (15) with the torus balloon (35) having balloon attachments (365)made directly to the stent frame (15) or to the ferrules (250). Thewaist (10) can be a portion of a stent frame (15) of a single memberstent-valve (5) or for a first component (200) (i.e., support member) ofa dual member stent-valve (195). The balloon attachments of the balloonto the stent frame (15) can be via an adhesive, via thermal bonding, viaencapsulation of the stent struts (267) with a polymer, via sutures, orvia other attachment methods available to the medical device industry.The torus balloon (35) is attached to stent frame (15) along the stentframe perimeter (375); the torus balloon (35) extends around the insideof the barb struts (260). As shown in FIG. 9A the torus balloon (35) isin a deflated configuration, the inner perimeter and outer perimeter(385) of the torus balloon (35) in a deflated configuration having aflattened shape and similar inner and outer perimeter (385) as seen inFIGS. 9A and 9B; the torus balloon (35) extends around the inside orframe luminal side (345) of the barb struts (260) and also can beattached to the stent frame.

As shown in FIG. 9C the torus balloon (35) is inflated therebyinterfacing with and applying a radially directed balloon outward force(228) to the barb strut (260) causing the barb tip (255) to extend tothe outside (350) of the stent frame (15) by 3 mm (range 2-5 mm). Thetorus balloon outer perimeter (385) of the inflated torus balloon (35)of this embodiment has a balloon outer perimeter (385) that is equal to(range equal to 2 mm greater than) the stent frame perimeter (375) inthe waist. The torus balloon inner perimeter (388) is supported by abacking element (450) to allow the inflated torus balloon (35) to pushor move the barbs (25) outwards with an outward force (228) such thatthe barb tips (255) extend to the outside (350) of the stent frame (15).The torus balloon outer diameter (390) is equal to the stent framediameter (380) of the waist (10) and has a diameter of 35 mm (range28-45 mm). As shown in FIG. 9D the torus balloon inner diameter (395) inan inflated configuration is smaller than the torus balloon outerdiameter (390); the torus balloon cross sectional diameter (400) is 3 mm(range 2-10 mm). The larger torus balloon cross sectional diameterobtained during balloon inflation will provide greater travel distancefor the barb strut (260) to extend outwards from an inactive to anactive configuration. The larger torus cross section diameter alsoprovides a greater outward force (228) from the torus balloon (35)against the stent frame. The small torus balloon cross sectionaldiameter will not impact to a significant degree the profile of thestent-valve frame (15) in its delivered configuration and will allow aunrestricted blood flow through its central region in an inflatedconfiguration. The torus balloon inner diameter (395) in an inflatedconfiguration is 25 mm (range 15-31 mm). The torus balloon perimeter(388) provides an open central torus balloon lumen (386) that will notrestrict blood flow from the LA to the LV when the torus balloon (35) isinflated.

Inflation of the torus balloon (35) not only activates the barb causingthe barb tip (255) to extend into the tissues of the mitral annulus (20)but the torus balloon (35) also improves the contact of the stent frame(15) with the mitral annulus (20). Inflation of the torus balloon (35)causes the torus balloon cross section to take a circular crosssectional shape. This circular cross sectional shape counteracts thedesire of the torus balloon (35) to form a kink along its perimeter andhence provide an outward frame expansion force (405) to push the stentframe (15) into intimate contact with the mitral annulus (20). Thegreater the inflation pressure the greater the outward frame expansionforce (405) that can be applied to the stent frame. To improve theoutward frame expansion force (405) as well as the balloon outward force(228) pushing on the struts the inflation pressures can exceed 10atmospheres (range 5-20 atm), if necessary for full frame expansion andfor full barb activation. A fiber winding or a braid can be containedwithin the wall of the torus balloon (35) to provide increased strengthto the balloon and allow for higher levels of inflation pressure.Although much lower pressures of 5 atm (range 2-10 atm) are needed topush the barb struts (260) outwards, using a larger inflation pressurewill provide proportionally greater outward frame expansion forces (405)by the torus balloon (35) against the waist (10) of the stent frame. Insome embodiments of the present invention, portions of the torus balloon(35) makes direct contact with the tissues of the mitral annulus (20)and the inflation medium is held within the interior of the torusballoon (35) following delivery and release of the stent-valve; in theseembodiments the torus balloon (35) also contributes to forming animproved seal with the mitral annulus (20) to prevent perivalvular leak.

The torus balloon (35) can be formed from a variety of polymericmaterials used to form dilation balloons used in angioplasty. Anoncompliant material such as polyethylene terephthalate, for example,can be used to form the torus balloon (35). Alternately, a semicompliantmaterial such as Nylon, Pebax, or a compliant material such aspolyurethane can be used; the compliance curve will dictate theinflation pressure that is used to match the perimeter (375) of thestent frame (15) in an inflated configuration. The torus balloon (35)can be formed using balloon blowing processing, for example, in atorus-shaped mold that sets the torus shape into the equilibrium shapeof the torus balloon (35). The torus balloon (35) can have one balloonport (410) located at one end of the torus balloon (35) and a dead-endor leak-tight blockage at the other end of the balloon; alternately, thetorus balloon (35) can be formed with two balloon ports, one at each endof the torus balloon (35) as shown in FIG. 9D. The torus balloon (35)can also be formed into a complete loop or doughnut shape but with aballoon port to allow for inflation.

FIGS. 10A-10C show an embodiment having the torus balloon (35) containedin a balloon pocket (415) of a balloon holder (420) and having theballoon holder attached to the stent frame (15) via a holder attachment(425). The stent frame (15) can be used as a portion of a single memberstent-valve (5) device or as a support member (i.e., first component(200)) of a dual member stent-valve (195). The first component (200) canbe an adapter that is able to provide a fixed ring structure attached tothe annulus (20) into which a second component (190) (i.e., valvemember) can be positioned and implanted. FIG. 10A shows the balloonholder attached to the ferrule (250) of the waist (10) or attached tothe stent frame (15) wall structure on the inside of the stent frame(15) or stent frame luminal side (345). The balloon holder wraps aroundthe barb strut (260) toward the inside surface of the barb strut (260).The torus balloon (35) is placed within a balloon pocket (415) formedfrom the balloon holder in a deflated configuration as shown in FIG.10A. The balloon holder provides protection to the torus balloon (35)from accidental puncture of the balloon and allows direct attachment ofthe balloon holder with the stent frame (15) without potentiallydamaging the torus balloon (35). The balloon holder has an inner layer(430) that faces the luminal side (345) of the stent frame (15) and anouter layer (435) that faces the barb strut (260). The balloon caneither float freely within the pocket of the balloon holder or it can beheld in place via an adhesive, for example. Upon inflation of the torusballoon (35), the balloon assumes a circular cross sectional shape andapplies an outward force (228) against the barb and pushes the barb tip(255) to the outside (350) of the stent frame (15) as shown in FIG. 10B.As shown in FIG. 10C the balloon holder can be attached to the stentframe (15) at the ferrules (250), to the stent struts (267) of thewaist, to the bent regions of the stent frame. The holder attachment canbe made via sutures, adhesives, thermal bonding, entrapment of the stentframe (15) by the balloon holder, or other attachment methods.

The materials for the balloon holder (420) can include woven fabric,velour, fibrous films, porous films, polymer films that are commonlyused in medical device implants. The balloon holder (420) can also serveas a skirt or fabric covering (285) that covers the stent frame (15) andprevents flow of blood across the stent frame wall (440) of the stentframe (15) from the inside or luminal side (345) to the outside (350) ofthe stent frame (15). The balloon holder (420) can alternately becomprised of only one layer such as the inner layer (430) that faces theluminal side (345), for example, or only the outer layer (435) thatfaces the outside (350). The torus balloon (35) can be attached to theinner layer (430), for example, via an adhesive, for example. The innerlayer (430) or the outer layer (435) can serve as a fabric covering(285) that prevents fluid flow across the stent frame (15) from theluminal sided (345) to the outside (350) of the stent frame (15). Thispocket construction to hold the torus balloon (35) or use of an innerlayer (430) or use of an outer layer (435) to hold the torus balloon(35) and serve as a fabric covering (285) can be used in any of theembodiments found in the present specification of a stent frame thatcomprises a torus balloon (35).

Another embodiment for placement and attachment of the torus balloon(35) within the waist (10) region of a stent frame (15) that isapplicable to either a single member stent valve (5) or a firstcomponent (200) of a dual member stent-valve (195) is shown in FIGS.11A-11C. FIG. 11A shows a waist (10) of a stent frame (15) with adeflated torus balloon (35) being placed along the outside (350) of thestent struts (267) and along the inside or luminal side (345) of thebarb struts (260). The balloon can be attached to the stent struts (267)and/or the barb struts (260) via an adhesive, for example; the torusballoon (35) can alternately be allowed to move relative to the stentstruts (267) and barb struts (260). FIG. 11B shows a top view of twostent struts (267) and a barb strut (260) located in between the stentstruts (267); a portion of a torus balloon (35) is shown weaving to theoutside of the stent struts (267) and to the inside of the barb strut(260). Upon inflation of the torus balloon (35) as shown in FIG. 11C,the barb tip (255) is pushed outwards placing the barb tip (255) to thestent frame outside (350) and outside of the stent frame perimeter (375)formed by the two stent struts (267). In this embodiment the inflatedballoon outer diameter (390) is larger than the stent frame diameter(380) in the waist (10) at a location of the barb struts (260) and barbtips (255). The location of the torus balloon (35) on the outside (350)of the stent frame (15) and on the outside (350) of the stent struts(267) places the torus balloon (35) into direct contact with the tissuesof the mitral annulus (20) and the torus balloon (35) forms a directseal between the mitral annulus (20) and the stent frame. The torusballoon (35) can conform to irregularities in the shape of the mitralannulus (20) and form a continuous seal that will prevent perivalvularleaks between the stent-valve and the mitral annulus (20). The torusballoon (35) can serve as a skirt or fabric to seal the stent frame (15)from perivalvular leaks between the stent frame (15) and the mitralvalve tissues. Specific embodiments that use a polymeric material as aninflation medium (i.e., a crosslinking polymeric fluid that converts toa solid or elastomeric matrix or gel or foam) for the torus balloon (35)and also have the means (such as a duckbill valve, for example) toretain the polymeric inflation medium within the torus balloon (35) aresuitable candidates for forming such a seal between the torus balloon(35) and the tissues of the mitral annulus (20). Other embodiments canuse saline inflation fluid that is able to leak out of the torus balloon(35) through balloon port (410) (normally used for torus balloon (35)inflation) over time as described earlier in other embodiments.

FIGS. 12A-12C show yet another configuration for the torus balloon (35)placement along the waist perimeter (30) of the stent frame (15). Thestent frame (15) can be used as a portion of a single member stent-valve(5) or as a portion of a first component (200) (or adapter) for atwo-step (or dual member) stent-valve. In this embodiment the BE barbstruts (260) are attached to the stent frame (15) via an frameattachment members (442) such as a ferrules (250) located at the waistoutlet end (125). The BE barb strut (260) extends proximally within theinside of the stent frame (15) and has a barb tip (255) attached to thebarb strut (260), the barb strut (260) extending outwards but remainingwithin the inside of the stent frame perimeter (375) as shown in FIG.12A in an expanded configuration after the stent-valve has been releasedfrom the delivery sheath (105). A backing element (450) such as a stentarm (455) extends from the attachment member located at the waist outletend (125) towards the waist inlet end (215) at a stent arm angle (445)such that the proximal end (115) of the stent arm (455) is locatedinwards from the barb strut (260) toward the stent frame centerline axis(45) and inward from the barb tip (255). The stent arm (455) can be ametal strut attached to the stent frame, the stent arm (455) beingformed from a metal or polymeric material. The stent arm (455) is ableto provide adequate support such that the barb strut (260) will bendpreferentially as the stent arm (455) provides the back-up support for atorus-shaped balloon that is located between the barb strut (260) andthe stent arm. The torus balloon (35) is located towards the inside ofthe barb strut (260) and towards the outside of the stent arm; the torusballoon (35) extends along the perimeter (375) of the stent frame (15)between stent arms and barb struts (260) located at a plurality of 16(range 8-40) locations along the perimeter (375) of the stent frame; thetorus balloon (35) is in direct contact with the stent arm (455) of thestent frame; tissue from the heart valve is not located between thestent frame (15) and the torus balloon (35).

FIG. 12A shows the torus balloon (35) in a deflated configuration withthe barb tip (255) located on the inside of the stent frame; the stentframe (15) has been released from the delivery catheter and is in anexpanded configuration. The torus balloon outer perimeter (385) matchesapproximately the expanded stent frame perimeter (375). During deliveryof the stent frame (15) within the delivery sheath (105) in anonexpanded configuration, the torus balloon (35) would be folded alongits perimeter to allow for a smaller stent frame perimeter (375) andtorus balloon (35) in its nonexpanded configuration within the deliverysheath (105). The torus deflated balloon is located between the barbstrut (260) and the stent arm (455). One end of the torus balloon (35)is attached to a balloon port (410) that provides entry of inflationmedium to inflate the torus balloon (35); the other end of the torusballoon (35) has a dead end or closed end (460) that does not allowescape of inflation medium from the torus balloon (35).

Upon inflation of the torus balloon (35) as shown in FIG. 12B, the barbstrut (260) is pushed outwardly to the outside (350) of the stent frame(15) by the torus balloon (35) as the inflation forces from within thetorus balloon (35) are transferred from the stent arm (455) through thetorus balloon (35) to the barb strut (260) causing the barb strut (260)to extend outwards and placing the barb tip (255) to the outside (350)of the stent frame (15) and into the tissues of the mitral annulus (20).The torus balloon (35) of this embodiment is located along the perimeteron the inside or luminal side (345) of the stent frame. Followinginflation of the torus balloon (35) and activation of the barbs (25) toextend outwards from the stent frame (15) and into the mitral annulartissues, the torus balloon (35) of this embodiment can be removed asshown in FIG. 12C. Upon application of tension (465) at the location ofthe balloon port (which extends throughout the shaft of the deliverycatheter) the torus balloon (35) is pulled upwards such that it isremoved from a location between the barb strut (260) and the stent arm(455) as shown in FIG. 12C. The torus balloon (35) which is formed froma soft flexible polymeric material is able to unwind (as shown in FIG.12C) from its torus shape and be removed from its position between eachof the plurality of barb struts (260) and stent arms as balloon port isplaced under tension or during removal of the delivery catheter. Thetorus balloon (35) of this embodiment can be inflated with saline orother contrast medium to activate the barb struts (260) and barb tips(255).

The backing element (450) can alternately be a backing fiber (470) thatextends from an attachment element such as a ferrule (250) located atthe waist outlet end (125) of the stent frame (15) to an attachmentelement located at the waist inlet end (215) of the stent frame (15) asshown in FIG. 12D. The backing member (450) resides on the insideperimeter (388) of the torus balloon (35). The backing fiber can beformed from a multifilament or monofilament strand metal or polymericfiber that is flexible but has high tensile strength such that it willnot stretch upon exposure to inflation pressures imposed upon it by thetorus balloon (35). The backing fiber extends on the inside portion(i.e., nearest the stent frame (15) central axis (45)) of the torusballoon (35); the torus balloon (35) is located adjacent the inside ofthe barb strut (260) as shown in FIG. 12D. Upon inflation of the torusballoon (35) with contrast medium (as described in FIG. 12B), the barbstrut (260) is pushed outwards such that the barb tip (255) extendsoutwards from the stent frame (15) and into the tissues of the mitralannulus (20). The backing element (450) provides the support such thatthe inflation forces from the inflated torus balloon (35) aretransferred directly to the barb strut (260) causing the barb strut(260) to move outwards to the frame outside (350) during inflation ofthe torus balloon (35).

The torus balloon (35) is shaped like a doughnut and hence it is unableto provide significant outward force on its own (i.e., without a backingfiber (470), for example) to cause the barbs struts (260) to be deformedoutwards. Rather than apply an outward force, as would be the case witha cylindrically-shaped balloon, the torus balloon would easily bend intoan oval shape or form a kink when it is inflated under pressure since itis not supported in its central region. However placement of a backingfiber (470) or other backing element on the inside surface of the torusballoon as shown in FIG. 12D will allow the torus balloon internalpressure to be exerted outwards and cause the barb strut (260) to beforced outwards with a force equal to the applied outward force due tothe internal pressure within the balloon.

The torus balloon (35) of this embodiment can be removed followingactivation of the barb tips (255) in a manner similar to that describedin the embodiment of FIGS. 12A-12D by placing tension onto the balloonport and pulling proximally thereby unwinding the torus balloon (35)from its torus shape and removing it from the heart, the vasculature,and the body.

In an alternate embodiment the torus balloon (35) described in FIGS.12A-12D can be attached to the stent frame, the barb struts (260), orthe backing element (450) and can be implanted into the patient alongwith other portions of the stent frame (15) and stent valve. Theattachment of the torus balloon (35) to a portion of the stent frame(15) can be made using an adhesive, sutures, thermal processing, orother methods available to bond polymeric or metal components together.In this alternate embodiment, the torus balloon (35) can be filled witheither a saline based inflation medium which is allowed to drain or leakout of the balloon following balloon inflation. The torus balloon (35)alternately can be filled with a polymeric material that will cure orharden as described earlier; in this case, a check valve as described inearlier embodiments will be required to ensure that such polymericmaterial is confined to the inside of the torus balloon (35). Asdiscussed in earlier embodiments, a limiting cable (225) can be attachedanywhere along the axial length of the stent frame (15) or to the stentframe along a perimeter of the waist (10) in its expanded configurationand nonexpanded configuration.

The delivery of an inflation fluid to the torus balloon (35) anddetachment of the torus balloon (35) from a control shaft is shown inFIGS. 13A-14. FIG. 13A shows the torus balloon (35) having one balloonport; the torus balloon (35) is understood to be attached to the waist(10) as shown in any of the embodiments described in FIGS. 8-12, but isshown here for clarity as only the torus balloon (35) component of thestent-valve system. A control tube (475) is located within a pusher tube(122) that is located within the delivery sheath (105) similar to thatdescribed earlier in the embodiment shown in FIG. 1A. The control tube(475) and the pusher tube (122) can be a single tube in some embodimentsrather than two separate tubes. Contained within the control tube is ahollow control shaft (480) that provides a control lumen (485); thecontrol shaft with and inner control lumen are used to provide inflationfluid to the torus balloon (35). The inflation fluid is delivered to thetorus balloon (35) under pressure and hence the junction of the controlshaft with the balloon port of the torus balloon (35) should not leaksignificant amount of inflation fluid such that inflation pressure canbe attained and must be releasable by the operator at the proximal end(115) of the catheter.

FIGS. 13B and 13C shown one embodiment for a releasable attachment ofthe control shaft from the balloon port. The balloon port is formed witha locking intrusion (490) that extends inwards into the balloon portlumen (495). The control shaft is formed with 3 inner nubs (500) (range2-5 nubs) that extend inward into the control lumen as shown in FIG.13C. The control shaft also has an outer protrusion (505) that has anequilibrium diameter that is larger than the locking protrusion; controlslots (508) located in the control shaft (480) allow the control shaftto expand to a larger diameter when a mandrel (510) has been inserted.The outer protrusion of the control shaft can be pushed past the lockingprotrusion (to engage the control shaft with the balloon port) as longas there is not a mandrel present within the control lumen of thecontrol shaft. Once the control shaft is engaged with the balloon port,a mandrel (510) with a mandrel diameter (515) larger than an equilibrium(i.e., with no external forces impose upon it) nub diameter (520) isplaced within the control lumen to form a locked nub diameter to lockthe control shaft with the balloon port. Following inflation of thetorus balloon (35) via the control lumen, the barb will be activated,and the torus balloon (35) is ready to be disengaged. To disengage thetorus balloon (35), the mandrel is removed by applying tension to themandrel by the operator; with the mandrel removed, the control tube canbe removed from the balloon port by applying tension. The torus balloon(35) has therein been effectively inflated and released from the controlshaft.

FIG. 14 shows an embodiment that provides a releasable connection (488)comprised of a threaded connection (525) of the control shaft (480) tothe balloon port (410) via a screw mechanism. The distal end of thecontrol shaft is fitted with an outer thread (530) that fits within aninner thread (535) located within the balloon port. The control shaftlumen extends through the threaded region to allow for inflation of thetorus balloon (35). The control shaft is detached from the balloon portby turning to form a threaded release. A flapper valve (540) orduck-bill valve can be placed within the balloon port to prevent theinflation fluid from draining out of the torus balloon (35) afterballoon inflation. Saline can be used as an inflation fluid and allowedto drain out of the torus balloon (35) as described in earlierembodiments. Alternately a polymeric material such as a crosslinkingpolyurethane, epoxy, silicone, or other polymer or fluid can be used toinflate the torus balloon (35) of this or other embodiments and remainwithin the implanted torus balloon (35). For the embodiments that use apolymeric inflation medium, the balloon can serve to make a conformalpressure dependent seal with the mitral annulus (20) as it makes directcontact with the tissues of the mitral annulus (20).

FIG. 15 shows a side view of a segmented torus balloon (550) having asegmented shape that is located in the waist (10) of a stent frame (15)of the present invention used for a single member stent-valve (5) or afirst member (200) of a dual member stent-valve (195). The stent frame(15) and barb struts (260) are similar to the frames and barb struts(260) shown in FIGS. 8A-12B. The stent frame (15) is formed from a SEmaterial and the barb strut (260) is formed such that it is balloonexpandable such that it can bend outwards due to an radially outwardforce (228) against the barb strut (260) generated by inflation of asegmented torus balloon (550). In FIG. 15 the spherical segment (555) ofthe segmented torus balloon (550) is located adjacent to the barb strutinside surface (560) (i.e., facing the inside (345) of the stent frame)and is inflated with inflation medium such that inflation of thespherical segment (555) will push the barb strut (260) outwards suchthat the barb tip (255) extends on the stent frame outside (350) of thestent frame (15) as shown for one of the plurality of barbs (25) locatedalong the perimeter (375) of the stent frame. Each spherical segment(555) is located adjacent to an cylindrical segment (565) of a barbstrut (260). Each spherical segment (555) is joined to an adjacentspherical segment (555) by a cylindrical segment (565) that retains asmaller diameter during its inflated configuration. The diameter foreach inflated spherical segment (555) is 4 mm (range 3-10 mm) and thediameter of each cylindrical segment (565) is 2 mm (range 1-3 mm). Thecylindrical segments do not enlarge in diameter as the segmented torusballoon (550) is inflated. At one end of the segmented torus balloon(550) is located a balloon port that is attachable to a fill tube orcontrol shaft that provides inflation fluid to the segmented torusballoon (550). The other end of the segmented torus balloon (550) isdead-ended forming a closed end such that inflation fluid is not able toleak out of the closed end. The segmented torus balloon (550) of thisembodiment provides an advantage over a uniformly cylindrical torusballoon (35) as presented in earlier embodiments. The segmented torusballoon (550) can provide a greater excursion or travel distance to thebarb strut (260) due to the larger diameter spherical segment (555)while minimizing the profile for the torus balloon during delivery andduring inflation of the segmented torus balloon (550) due to the smallerdiameter cylindrical segments. During inflation of this segmented torusballoon (550), the cylindrical segments which are at least partiallylocated on the outside (350) of the stent frame (15) do not provide anincreased outward push against the mitral annulus (20) during inflationof the balloon since the cylindrical portions do not expand in diameterduring inflation. In this embodiment, the inflation fluid is saline andthe saline can be released or allowed to leak back into the patient'sblood following inflation of the torus balloon in a manner described inearlier embodiments for the torus balloon (35). The balloon is implantedalong with the remainder of stent frame (15) and the mitral valvedevice.

A top view of the segmented torus balloon (550) of this embodiment isshown in FIG. 16 in an inflated state. In FIG. 16 the cylindricalsegment (565) is shown extending on the outside (350) of the stent frame(15) adjacent to the stent struts (267). The spherical segments (555) ofthe segmented torus balloon (550) are located adjacent to thecylindrical segment (565) of the barb struts (260) located facing thestent frame inside (345). During inflation the barb tip (255) is pushedoutwards toward the stent frame outside (350) by the spherical segment(555) of the segmented torus balloon (550). The cylindrical portionretains its location on the outside (350) of the stent struts (267) andprovides the force necessary to allow the spherical segment (555) topush the barb struts (260) outwards toward the outside (350) of thestent frame. The cylindrical segments can be attached to the stentstruts (267) via balloon attachments to hold the segmented torus balloon(550) in position against the stent frame.

The segmented torus balloon (550) can be formed from similar materialsas described earlier for the torus balloon (35). The segmented torusballoon (550) as shown in FIG. 17 can be formed with a series of bulgesor spherical segments (555) using polymeric materials and processingmethods used to form current dilation balloons used in medical devices.The balloon can be formed with smaller diameter cylindrical segments inseries with spherical segments (555); the balloon can have one balloonport located at one end of the balloon; the other end can be closed offand formed to be leak tight forming a closed end (460). Polymericmaterial for the segmented torus balloon (550) can include polyethyleneterephthalate, nylon, Pebax, polyurethane, composites, copolymers, andother polymeric materials used to form dilation balloons for angioplastyand stent delivery catheters.

A shaped mold having regions with bulges can be used to form thesegmented torus balloon (550) having spherical segments (555) andcylindrical segments. The mold has bulges or spherical mold segmentslocated in series with smaller diameter cylindrical segments. Standardballoon blowing and molding techniques can be used to form the segmentedtorus balloon (550). The segmented torus balloon (550) can alternatelybe formed by bonding segments of cylindrical tubing to other segmentshaving a spherical shape; such bonding can be accomplished via solventbonding, adhesive bonding, thermal bonding or other suitable bondingmethod.

In other embodiments for the segmented torus balloon (550) of thepresent invention, the segmented torus balloon (550) can be inflatedwith a polymeric material and retained within the balloon via a valve asit is implanted as described for other embodiments for the torus balloon(35). Also, in other embodiments, the segmented torus balloon (550) canbe located such that the cylindrical segments are located on the insideof the stent frame (15) and attached by balloon attachments as describedin earlier embodiments for the torus balloon (35).

In further alternate embodiments of the present invention used as asingle member stent-valve, the barb struts (260) that are used to holdthe stent frame (15) adjacent to the mitral annulus (20) and preventmigration of the stent valve can be attached, joined, or contiguous withthe upper bulb (70) or the housing (130) rather than attached, joined,or contiguous with the waist (10) of the stent frame. In one embodiment,as shown in FIG. 18, the stent frame (15) does not have a cylindricalwaist (10) portion and instead has a frustum-shaped housing (130) thatis directly joined to the upper bulb (70). The barb struts (260) of thisembodiment are located within or attached to the housing (130) portionand the barb tip (255) is located near the bulb/housing junction (568).The BE barb struts (260) are pushed outward due to expansion of thetorus balloon (35); the torus balloon (35) can be the segmented torusballoon (550) or a torus balloon that is cylindrical throughout asdiscussed in earlier embodiments. The torus balloon (35) can be locatedon the outside (350) of the stent struts (267) and outside (350) of thestent frame (15) as shown in FIG. 18 and having a segment of the balloonlocated on the inside of the barb struts (260) such that inflation ofthe balloon pushes the barb struts (260) outwards. The torus balloon(35) can alternately be located on the inside of the stent frame (15)such that inflation of the torus balloon (35) does not push the stentframe (15) away from the mitral annulus (20). The replacement leaflets(270) are located near the outlet end (145) of the housing.

Alternately, as shown in FIG. 19 for an embodiment of a single memberstent-valve, the barb struts (260) and torus balloon (35) can be joined,attached, or contiguous with the upper bulb (70). In this embodiment,the upper bulb (70) is joined directly to the housing (130) and does notcontain a cylindrical waist (10) region located between the upper bulb(70) and the housing (130). The barb tips (255) are located near thebulb/housing junction (568) such that the barb tips (255) are extendedoutwards via inflation of the torus balloon (35) and extend the barbtips (255) into the mitral valve annulus (20). The torus balloon (35)can be located such that it weaves in an out over the outside (350) ofthe stent struts (267) and adjacent the inside of the barb struts (260)as described in earlier embodiments. Alternately, the torus balloon (35)can be located on the inside surface of the stent frame (15) as well asthe cylindrical segment (565) of the barb struts (260) as describedearlier.

FIGS. 20A and 20B show an embodiment for a first component (200) (orsupport member) of a two component or dual member stent-valve. Thesupport member (200) provides a ring like structure (via the limitingcable (225)) having a defined maximum perimeter (375) for the frame (15)that is attached to the mitral annulus (20) via barbs (25), and does notinterfere with the function of the native mitral valve leaflets. A valvemember (or second component (190)) that contains replacement leaflets(270) provides a second component (190) that is delivered within thecentral lumen (265) of the first component (200) and is held in placevia a friction fit or via geometrical locking of the first component(200) with the second component (190). The first component (200) can bean adapter into which the second component (190) containing thereplacement leaflets (270) can be positioned and implanted. The secondcomponent (190) can be a specific stent-valve such as presented inembodiments of this patent application; the second component (190) canalternately be an existing stent-valve, such as a BE or SE stent-valveused in TAVR procedures, for example.

The first component (200) has a self-expanding (SE) stent frame (15)that is comprised of a frame waist (10) that can be attached to orcontiguous with the upper bulb (70). A valve member or second component(190) which will be discussed in a later embodiment is deliveredsubsequent to the delivery of the first component (200) within the opencentral lumen (265) located of the first component (200); the secondcomponent (190) is attached to the first component (200) via friction orgeometrical fit to the first component (200) that is obtained byexpanding the second component (190) within the first component (200).The SE stent frame (15) of the first component (200) can be formed fromNitinol, Elgiloy, or other elastic material used in the formation ofvascular stents. The waist (10) is positioned adjacent the mitralannulus (20) and the upper bulb (70) may be located in the LA (80)adjacent to the mitral annulus (20); the upper bulb (70) has a diameterat its inlet end that is larger than the waist inlet diameter (55) toassist in positioning the stent frame (15) across the mitral annulus(20) with the upper bulb (70) resting in the LA, adjacent and upstreamof the mitral annulus (20). Positioning of the stent frame (15) intocontact with the native mitral valve apparatus tissue is performed viarelease from an external sheath using a pusher member (122) as describedin earlier embodiments described in the present application and patentapplications that are referenced in the present application. Recapturestruts (100) can be attached to the upper bulb (70) or the waist (10) ofthe present stent frame (15) to assist in repositioning or removal ofthe first component (200) in a manner consistent with the stentembodiment described in earlier embodiments. The first component (200)serves to provide a stable location that will hold a second component(190) that contains the replacement leaflets (270) for the mitral valvesystem of the present invention. The first component (200) allows thesecond component (190) to be expanded within the inside of the firstcomponent (200) and the first component (200) has a specific waistdiameter that provides the necessary frictional force against the secondcomponent (190) or geometrical shape to hold the second component (190)from migrating downstream and ensuring that leakage does not occurbetween the first component (200) and the second component (190). Alimiting cable (225) can be placed along the perimeter (375) of thestent frame (15) of the first component (200) to limit the stent framediameter (380) and perimeter (375) of the stent frame (15) from furtherexpansion due to outward forces from the frame of the first component(200) or second component (190) or from an inflation balloon; thelimiting cable allows the second component (190) to be expanded into thefirst component (200) under a greater force (greater than without thelimiting cable (225)) that is at least equal to a 10 atm cylindricaldilation balloon to create a tight fit between the first and secondcomponent (190). The first component (200) must also be placed withinthe mitral valve apparatus in a manner that will not affect thefunctioning of the native mitral valve leaflets during the period oftime while awaiting the placement of the second component (190) into thefirst component (200). In the present invention the first component(200) is placed above or superior to the mitral valve leaflets andextends from the junction (570) of the native mitral valve leaflets tothe mitral annulus (20) and can come into contact with the junction(570) of the native mitral valve leaflets with the annulus (20). Thenative mitral valve leaflets are able to function while the firstcomponent (200) is placed adjacent to the mitral annulus (20) and othernative tissues of the native mitral apparatus.

The upper bulb (70) of the first component (200) serves to help preventmigration of the first component (200) toward the LV (165), to provide aseal to prevent blood leakage between the first component (200) and themitral tissues including the LA (80) wall, mitral annulus (20), andmitral leaflets, and to assist in positioning of the first component(200) across the mitral annulus (20) with the upper bulb (70) beinglocated in the LA just proximal to the annulus (20). As shown in FIG.20A, the barbs (25) which are comprised of barb struts (260) (range 8-20in number) and barb tips (255) are located along the waist perimeter(30) (see FIG. 20B); the barbs (25) can be formed from a SE elasticmaterial such as Nitinol, for example, or can be formed from a BEmaterial such as stainless steel, for example or from other metals orpolymers. Prior to delivery of the first component (200) the barbs (25)are in an inactive configuration located toward the inside of the firstcomponent (200) in the central lumen (265) as described in earlierembodiments. Upon activation of the SE or BE barbs (25) outwards to theoutside (350) of the waist, the barb tips (255) penetrate the mitralannulus (20) as shown in FIG. 20A or penetrate the base of the nativemitral leaflets near the mitral leaflet junction (570) with the mitralannulus (20). Activation of the barbs (25) into the mitral tissuesprevents migration of the first component (200) upstream (202) towardsthe LA (80) and also prevents migration downstream into the LV.

The barb tips (255) can be formed from a material with a sharp tip thatcan penetrate the tissues of the mitral annulus (20) or the base of thenative mitral leaflets. The barb tips (255) can be formed with aflattened shape such that the surface area of the flat barb tip (255)(see FIG. 20C) is maximized in a direction facing the LA (80) or LV toresist movement of the first component (200) towards the LA (80) or LV(165). Other embodiments for the barb tip (255) are contemplated thatwill help to provide a greater holding force yet still allow the barbtip (255) to be withdrawn acutely under the circumstance that theoperator would prefer to deactivate or remove the barb tips (255) fromthe surrounding tissues and reposition or remove the device. In oneembodiment, for example, a fish hook that has been coated with polyL-lactic acid (PLLA) can be used as a barb tip (255). The fish hook canbe coated to form a conical shape, for example, similar to those shownin FIG. 20A or 20C for delivery into the surrounding tissues. After thePLLA has had a chance to biodegrade over a time of days or weeks, thestandard fish hook shape can become uncovered and can hold thesurrounding tissues with greater strength and prevent deactivation ofthe barb tip (255) from the surrounding tissues in a manner similar to afish hook. Other shapes can be used for the barb tip including a coiledtip such as that used, for example, on the tips of specific pacemakerleads. The coiled tip can be coated with PLLA, for example, to transformthe shape of the barb tip (255) into a conical shape, for example, suchas that shown in FIGS. 20A and 20C. After delivery of the PLLA-coatedcoiled tip to the surrounding tissues via the outward forces of thetorus balloon (35), the PLLA can be degraded and leave a barb tip withgreater surface area and greater potential holding power to preventdeactivation of the barb tip out of the surrounding tissues. Other tipshapes can be used to form the barb tips (255) of the present invention,and other biodegradable materials can be used to provide a coating tothe barb tip (255) including biodegradable materials used inbiodegradable stents and other biodegradable medical devices. Barb tips(255) can be any element or member that is able to engage thesurrounding tissue and prevent the migration or embolization of thefirst component (200).

A covering (285) can be attached to all or a portion of the frame waist(10) and upper bulb (70) frame to prevent blood flow from crossing thewall of the waist frame or the upper bulb (70) frame; the covering (285)can be located on the inside or outside surface of the stent frame (15)and helps to ensure that perivalvular leakage around the stent frame(15) is minimized. The covering (285) material can be a thin polymericfilm or weave, for example, as described in earlier embodiments.Attachment of the covering (285) to the frame (15) can be via sutures,adhesives, and various bonding methods.

One important aspect of the of the present invention is that the barbs(25) are not released or activated until the stent frame (15) has beenexpanded into the native mitral tissues and is in an expandedconfiguration. Activation of the barbs (25) after the SE stent frame(15) is expanded and placed into full contact along the entire perimeterof the waist (10) with the full perimeter of the mitral annulus (20) andother mitral tissues ensures that the barbs (25) are placed evenlyaround the perimeter of the mitral annulus (20) and mitral tissues.Since the mitral annulus (20) and base of the mitral valve leafletjunction (570) to the mitral annulus (20) is not actually round in shapein its native configuration, the mitral tissues will be forced into around shape by the waist stent frame (15) prior to activation of thebarbs (25). The rounding of the mitral annulus (20) by the stent frame(15) of the present invention is not restricted by undesirable prematureactivation of barb tips (255) into the mitral annulus (20) perimeter inan incorrect position which could occur if the barbs (25) were activatedprior to full expansion of the stent frame perimeter (375) into contactwith the perimeter of the annulus (20). Premature activation of the barbtips (255) would result in uneven spacing of the barbs (25) around theperimeter of the mitral annulus (20) or base of the mitral leaflettissues and would not allow the mitral annulus (20) to fully enlarge toa round shape representative of the perimeter of the mitral annulus(20).

Another important aspect of the first component (200) of the presentinvention is that during activation of the barbs (25), the blood flowthrough the mitral annulus (20) or stent valve frame (15) should not beblocked. Blockage of mitral blood flow can result in high forces beingplaced onto the first component (200) during the systolic cycle of heartpumping; such forces can cause movement of the first component (200)towards the LA (80) negatively affecting the positioning of the firstcomponent (200) accurately in an axial direction (90) across the annulus(20). The use of a torus balloon (35) prevents the unwanted blockage ofblood flow during delivery of the first component (200) and activationof the barbs (25) with the torus balloon (35). Additionally, mitralblood flow blockage can negatively impact oxygen transport to tissuesfed by the outflow from the heart including the brain.

FIGS. 21A and 21B show one embodiment for activation of BE barbs (25)that are located along a waist perimeter (30) of the first component(200) of the present embodiment or along the waist of the single memberstent-valve (5) described earlier. The frame has been released and hasexpanded out to an expanded configuration (575); the barbs (25) have notbeen activated as shown in FIG. 21A. The first component (200) of thisembodiment has an upper bulb (70) attached to the waist, the upper bulb(70) provides a benefit for proper placement of the first component(200) adjacent to the mitral annulus (20) and assisting with forming aseal between the frame (15) and the mitral annulus (20). The waist (10)of the first component (200) is similar to the waist that is describedin earlier embodiments found in the present patent application. Thewaist can be cylindrical in shape or can have a concave or curved shapeas will be described in other embodiments. The waist can have a waistlength (332) in an axial direction (90) of 6 mm (range 3 mm-10 mm) andis formed from a stent structure that is open cell, closed cell, acombination of open and closed cell, or other structure found invascular stents used in the medical device industry. The waist is placedadjacent to the mitral annulus or native mitral valve tissue such thatthe first component frame does not affect the movement or valvularfunction of the native mitral valve leaflets. In this embodiment, asdescribed earlier for a single member stent valve (or one-step mitralvalve device having the replacement leaflets (270) contained within thestent frame (15) that is attached or contiguous with a waist frame) atorus balloon (35) is inflated to apply an outward force (228) onto thebarbs (25) causing the barb tips (255) to move outwards to the stentframe outside (350) and into the annulus (20) or tissue of the heartvalve. In this embodiment a backing element (450) such as a stent arm(455) serves to provide a member that is attached to the stent frame(15) and provides the torus balloon (35) with a backing member of whichthe torus balloon (35) can be located in an uninflated configuration asshown in FIG. 21A and with the barb in an inactivated state. Theinflated balloon can push against the barb strut (260) to cause the BEbarb strut (260) to extend and plastically deform towards the outside(350) of the stent frame (15) and into the mitral tissues in anactivated configuration as shown in FIG. 21B. The backing member (450)provides the support to allow the torus balloon (35) to push with anoutward force (228) that is equal to its internal inflation pressure toextend the barb tips to the frame outside (350) and into the surroundingtissues of the heart valve. The first component (200) of the presentinvention can utilize any of the device mechanisms described in earlierembodiments of the present patent application to activate the barbs (25)into the mitral tissues. For example, the first component (200) can havethe torus balloon (35) attached to the waist frame or the stent frame(15) as described in FIGS. 8A-8D and 9A-9D. Alternately, the torusballoon (35) for the first component (200) can be located in the waist(10) region of the first component (200) and can be located in a balloonholder and attached to the frame (15) and activated in a manner that isthe same as that described in FIGS. 10A-10C. The torus balloon (35) ofthe first component (200) of the two step embodiment can have the torusballoon (35) located on the outside of the struts (267) of the framewaist (10) and on the inside of the barb struts (260) as shown in FIGS.11A-11C. The torus balloon (35) of the first component (200) can bepermanently attached to the first component (200) and implanted alongwith the first component (200) or can be removable as described in FIGS.12A-12D. The torus balloon (35) of the first component (200) can be asegmented balloon as described in FIGS. 15 and 16.

FIGS. 22A and 22B show another embodiment for the first component (200)for the mitral valve assembly of the present invention. This embodimenthas a waist (10) and upper bulb (70) that is similar to that describedin FIGS. 21A and 21B. The barb struts (260) for this embodiment are SEbarb struts (260) rather than the BE barb struts (260) found in theembodiment of FIGS. 21A and 21B. This embodiment does not require thepresence of a torus balloon to effect the active deployment of thebarbs. The barb struts (260) are attached to the frame (15) in a mannersimilar to that described in earlier embodiments of the present patentapplication. The barb struts (260) have a barb feature (578) that allowspassage of a barb control fiber (585). A backing element (450) such as abacking arm, for example, is attached to the stent frame (15) to providea holding member that can hold the barbs (25) in an inactiveconfiguration as shown in FIG. 22A. The backing arm has an openingfeature (580) that allows passage of a barb control fiber (585). Thebarbs (25) are held in an inactive configuration towards the inside ofthe stent frame (15) via barb control fibers (585) that temporarily holdthe barb struts (260) with respect to the backing elements (450) byconnecting or interfacing between the opening feature of the backing armand the barb feature of the barb strut (260). The barb struts (260) arerelease by applying tension via the operator to the control fibers (585)that extend to the proximal end (115) of delivery catheter locatedoutside of the patient's body thereby releasing the barb struts (260)and placing the barb tips (255) to the outside (350) of the waist (10)stent frame (15) during barb activation as shown in FIG. 22B.

FIG. 23A shows a cylindrically-shaped waist (10) for the first component(200); the waist (10) being positioned adjacent the mitral annulus (20);the waist (10) can alternately be a portion of a single memberstent-valve (5) as described in earlier embodiments. The upper bulb (70)is attached to the upstream end of the waist; the upper bulb (70)extends outwards to a larger upper bulb diameter (75) than the inletwaist diameter (55) as the upper bulb extends into the LA (80) at anupper bulb angle with respect to the waist of 45 degrees (range 20 to 90degrees). One or more limiting cables (210) are attached to the waist,the limiting cables (210) extend around the perimeter (30) of the waist(10) and prevent the waist (10) from expansion to a larger perimeterthan the perimeter of the limiting cables (225). As shown, one limitingcable (225) is located at the upstream end of the waist (10) near thewaist inlet end (215) and one is located at the downstream end of thewaist near the waist outlet end (125). The limiting cables (225) can beformed from polymeric or metal material and can be either a monofilamentor multifilament strand. The limiting cable (225) is attached to thestent frame (15) via welding, brazing, adhesive bonding, swaging, orother attachment methods used in the medical device industry. Thelimiting cable (225) is described also in earlier embodiments found inthe present patent application. FIG. 23B shows the waist (10) of thefirst component (200) having a curved shape or curved waist (40). Thewaist central diameter (50) is 3 mm (range 2-10 mm) smaller than thewaist inlet diameter (55) at the upstream end (215) or the waist outletdiameter (60) at the downstream end (125) of the waist (10). The curvedwaist (40) shape for the first component (200) can provide a concaveregion (42) or hump which extend into the central lumen (265) space thatwould allow a groove or concave region (42) of a second component (190)to lock into position with respect to the first component (200) andwould prevent the second component (190) from migrating upstream (95)toward the LA (80) or downstream toward the LV with respect to the firstcomponent (200).

Embodiments of the second component (190) of the two-step stent-valvesystem are shown in FIGS. 24A and 24B. FIG. 24A shows a stent-valve thatcould be used for a TAVR device or other stent-valve device applicationbut instead is being applied as a second component (190) of a two-stepmitral valve system. The second component (190) stent-valve has a valveframe (192) structure that contains replacement valve leaflets (270)attached to the frame (15) via crown-shaped attachments as described inearlier embodiments. The leaflet material and attachment of the leafletsto the valve frame (192) are as described in other embodiments of thepresent patent application. The stent-valve could have a BE stent-valveframe (192) that is formed from a BE material such as stainless steel orit can have a SE stent-valve frame (192) that is formed from Nitinol,for example. The stent valve of the second component (190) can have acylindrically-shaped frame (15) as shown in FIG. 24A; the stent-valvecan have an upper bulb (70) extend outwards into the LA (80) as shown inFIG. 24B; the stent-valve can have a frustum-shaped housing (130) thatholds the replacement valve leaflets as shown in FIG. 24C. Thefrustum-shaped housing (130) provides an advantage over a cylindricallyshaped housing (130) in that it does not impinge upon the LVOT bloodflow area; the replacement leaflets (270) can be formed with a frustumshape as described in earlier embodiments of the frustum housing (130)thereby reducing the amount of force on the leaflet free edge when theleaflets are closed during systole.

The second component waist (205) of the second component (190) can havea second component concave region (206) that matches the curved shape ofthe first component concave region (211) of the first component waist(210) as shown in FIG. 24D. The second component waist (205) of thesecond component (190) can be delivered to a location within the mitralvalve apparatus such that upon expansion of the second component (190)on the inside of the first component (200), the second component curvedwaist (205) tends to self-adjust itself such that the second componentconcave region (206) is located adjacent to the first component concaveregion (211). The second component concave region (206) will lock withrespect to the first component concave region (211) thereby preventingmigration of the second component (190) with respect to the firstcomponent (200). The first component concave region (211) is a lockingregion that is able to form a geometrical or locking fit with the secondcomponent concave region (206). Other locking region geometries arecontemplated; the locking regions have a geometry that is distinguishedfrom neighboring regions of the frame (15) adjacent to the lockingregion for the first component (200) or the second component (190).

FIG. 24E shows an embodiment of the dual member stent-valve (195) of thepresent invention having both the first component (200) and secondcomponent (190). The first component or support frame (200) wasimplanted initially within the lumen of the native mitral heart valve.The first component (200) has a SE stent frame (15) that was deliveredvia a delivery sheath (105) to a location adjacent to the mitral annulus(20) without affecting the native mitral valve function. An upper bulb(70) was extending outwards in the LA (80) to help position the frame(15) such that the waist extended across the annulus (20) and the upperbulb (70) was located in the LA. The profile of the first component orsupport frame (200) was very low due to the lack of replacement leaflets(270); hence the first component (200) was easily delivered by crossingthe atrial septum. The first component (200) was allowed to expand outinto contact with the mitral annulus (20) or other native mitral valvetissue without affecting movement of native mitral valve leaflets andnot affecting their valvular function prior to activating the barbs (25)via a torus balloon (35) which is attached to the first component (200)as described in earlier embodiments. The torus balloon (35) allows bloodto pass through the first component (200) and hence there is no shearforces or pressure forces that act to change the position of the firstcomponent (200). The torus balloon (35) can be inflated with saline suchthat leakage of inflation fluid is not of concern; detachment of thetorus balloon (35) from the delivery catheter is easy since theinflation fluid is allowed to leak out of the torus balloon (35) as itis implanted. If the position of the first component (200) was notacceptable to the operator, it would have been withdrawn into thedelivery sheath (105) via recapture struts (100) prior to activation ofthe barbs (25). The first component (200) has a limiting cable (225)around the perimeter (30) of the waist (10) to ensure that the secondcomponent (190) can be expanded into it and obtain a good frictional orgeometrical fit.

Once the first component or support frame (200) has been delivered, a SEsecond component (190) is delivered into the open central lumen (265)provided by the first component (200). The second component waist (205)has a curved waist (40) with a second component concave region (206)that matches the first component concave region (211) of the firstcomponent (200) thereby locking the first component (200) with thesecond component (190). A covering on the first component concave region(211) and the second component concave region (206) assist in preventingleakage of blood from between the first component (200) and the secondcomponent (190). The second component (190) is released within the opencentral lumen (265) of the first component (200) and makes contact longa continuous perimeter with the first component (200) in the lockingregion or the concave regions such that blood flow is not allowed toleak between the first component (200) and the second component (190).The second component (190) can have a cylindrical housing (130) for thereplacement leaflets (270) or the downstream end (145) of the housing(130) can be smaller in diameter than the housing inlet end (592) toensure that the LVOT is not impeded.

The second component (190) can alternately be formed with a BE frame(15) and can be delivered via a cylindrical dilation balloon (588) or anexpandable mechanical devices that can enlarge to form a largerconfiguration that would expand out a BE stent-valve. The BE secondcomponent (190) can have a second component concave region (206) thatfits the first component concave region (211) of the first component(200). The BE second component (190) can be expanded under largeinflation pressures or expansion forces such that the BE stent frame(15) of the second component (190) is deformed plastically around thelimiting cable (225) of the first component (200) to cause a frictionaland geometrical fit with the first component (200).

The BE stent-valve frame (15) can be delivered such that the stent frame(15) of the second component (190) of the dual member stent-valve ispositioned adjacent the waist (10) of the first component (200) as shownin FIG. 25. A cylindrically-shaped dilation balloon (588) located on theluminal side (345) of the stent-valve frame (15) can apply an outwardframe expansion force (405) to the frame (15) of the BE second component(190) stent valve into intimate contact with the waist (10) of the firstcomponent (200). The dilation balloon can also help to further apply anoutward radial force (228) onto the barbs (25) to force the barb tips(255) outwards further into the annulus (20) or tissues of the heartvalve. The limiting cables (210) located along a frame perimeter (375)of the first component (200) act to prevent over-expansion of the secondcomponent (190) to a diameter that could stretch the mitral annulus (20)potential causing injury to the patient. The limiting cables (210) alsoprovide limit to the frame perimeter (375) that the first component(200) can attain thereby allowing the second component (190) to expandwith a maximal frame outward force (65) that ensures maximal frictionalcontact between the second component (190) and the first component (200)thereby reducing the liklihood of migration of the second component(190) with respect to the first component (200), without the risk ofover-expansion of the first component (200). The limiting cable of thefirst component (200) also allows the second component (190) to beexpanded and deformed (by a dilation balloon, for example) such that thesecond component (190) forms a narrow waist (10) region adjacent to thelimiting cable of the first component (200) such that the secondcomponent waist (205) of the second component (190) has an hour-glassshape that fits via a geometrical lock with the first component (200).Geometrically shaped waist (10) regions for the first and secondcomponent (190) can also help to ensure that undesirable axial movementof the second component (190) are prevented

For the embodiment where the second component (190) has a SE stent-valveframe, the SE second component (190) is delivered via an externaldelivery sheath (105) that holds the second component (190) into anon-expanded configuration and delivers the second component (190) to alocation adjacent the native mitral apparatus such that the frame waist(10) of the second component (190) is located adjacent the frame waist(10) of the first component (200) as shown in FIGS. 26A and 26B.Recapture struts (100) can be attached to the waist (10) or upper bulb(70) of the second component (190) (see FIG. 26A); the recapture struts(100) can attach to holding features (110) located at the upstream end;the holding features (110) allow control fibers (120) to be loopedthrough them and extend through the delivery sheath (105) to theproximal end of the delivery sheath outside of the body. The controlfibers (120) allow the second component (190) to be retrieved orrepositioned as described in earlier embodiment presented in the presentpatent application such as the embodiment presented in FIG. 1A. Thesecond component (190) is released from the external sheath and expandsoutward into contact with the first component (200) as shown in FIG.26B. Frictional forces hold the second component (190) from migrationwith respect to the first component (200); geometrically shaped waist(10) regions or curved waist (40) regions for the first component (200)and second component (190) also assist in preventing migration of thesecond component (190). Release of a SE stent-valve is provided by apushing member contained within the delivery sheath (105) as is known inthe industry for delivery of SE stented devices.

The replacement leaflet (270) for the present invention can be formedfrom tissues taken from animal pericardium, xenograft heart valve,allograft heart valve, or other tissue or collagen materials.Alternately, the replacement leaflets (270) can be formed from a thinlayer of polymeric material such an expanded polytetrafluoroethylene(ePTFE), Dacron film, polymeric woven, braided, or knitted material.Often a polymeric material that is exposed to continued stress will tendto creep, therefore many of the polymeric films and some of the tissueor collagen materials used for valve leaflets will need to be supportedby fibers or thin films made from stronger materials that will not creepunder stress. Such stronger support fibers and films include Dacronfibers, thin multifilament metal fibers, thin metal films such asNitinol films and other materials of similarly high tensile strength andlow creep; such films and fibers can have diameters and thickness of0.001 inches (range 0.0003-0.002 inches) and can be very flexible.

The semi-lunar valve leaflets of the present invention are attached tothe wall of a cylindrical stent frame in a crown-shape attachment (595)path as shown in FIG. 27A. The free edge (295) of the valve leafletcomes into direct contact with a neighboring leaflet and a portion ofthe valve leaflet coapts with the neighboring leaflet. A leaflet pocket(600) is formed in the leaflet between the leaflet downstream surface(605) and the stent frame (15) as shown in FIG. 27B. Downstream (608)flow of blood through this valve is shown in an upward direction withblood flow leaving through the free edges (295). The leaflet pocketchanges shape as the leaflet moves from an open configuration withleaflets positioned adjacent or near the wall of the stent frame (15) toa closed configuration as shown in FIGS. 27A and 27B. The leaflet pocketallows the leaflets to coapt over a coaptation surface (610) duringsystole when the leaflets are closed and neighboring leaflet surfacesnear the free edges (270) contact each other for an axial distance of 3mm (range 1-6 mm) forming leaflet coaptation; blood flow via a directedflow and via a recirculation pattern over the coaptation surface of theleaflets during diastole ensures that thrombus does not develop on thesurfaces of the leaflets. The leaflets flex via extension in both theleaflet axial direction (615) and the circumferential direction (620)(see FIG. 27C) as they move from an open position as shown in FIG. 27Cto a closed position.

The leaflet support fibers extending circumferentially can provide therequired circumferential strength with minimal strain of less than 10%;axial support fibers provide more flexing and strain (i.e., 15%) to formthe valve leaflet pockets and assist in leaflet coaptation. Leafletsupport fibers can be attached to the leaflets to allow leafletexpansion to occur in a controlled manner, also support fibers canprovide a location by which the leaflets can be attached to the stentframe (15) of the present invention, further support fibers strengthenthe free edge of the leaflets to prevent the free edge from encounteringirreversible stretching. An embodiment for three semi-lunar leafletsthat are found as replacement leaflets (270) in the present stent-valveassembly is shown in a splayed-out manner in FIG. 27D. The crown-shapedleaflet attachment (275) path for three leaflets is shown; the crownshaped path is intended to be attached to the stent frame; thesemi-lunar valve can be formed with two or four leaflets, instead ofthree, for example, without deviating from the present invention.

One embodiment for the semi-lunar replacement leaflets (270) of thepresent invention is shown in FIG. 28A. The leaflets are formed from apolymeric film that is formed via either a film casting process, anextrusion process, or other film forming process. In this embodimentfibers (628) formed from Dacron, Nitinol, or stainless steel, forexample, are embedded within the polymer matrix of the leaflet polymericfilm, such as polyurethane, for example, as shown in FIGS. 28A and 28B.The fiber can also be attached to collagen matrix material or tissuesurfaces used to form the leaflets, the fibers can also be attached totissue valve leaflets via adhesives, sutures, or other bonding methods.The fibers include circumferentially oriented fibers (625) and axiallyoriented fibers (630). A free-edge fiber (635) can extend along or nearthe free edges (295) of the leaflets in a circumferential direction; anattachment-edge fiber (640) can extend along the attached edge (642) ofthe leaflets in a circumferential direction. One or more axial fiberscan extend from the free-edge fiber to the attachment-edge fiber; axialfibers can be attached to free-edge fibers or attachment-edge fibers atfiber attachment sites (632) via brazing, soldering, welding, adhesives,swaging, thermal bonding, solvent bonding, knotting, or other bondingmethods. The circumferentially oriented fibers and axially orientedfibers can be embedded within the polyurethane, collagen, or tissuematrix; the polymer or tissue matrix can be solvent cast or thermallycast around the fibers as shown in FIG. 28B forming a polymeric film(645) that can be used as a valve replacement leaflet. Alternately, twoseparate films of polyurethane or tissue matrix can be placed onto eachside of the fibers and heated to thermally bond the two film layerstogether or bonded together via adhesives, solvent bonding, or otherbonding method thereby forming a sandwiched fiber (650) as shown in FIG.28D; the sandwiched fiber film is used as a replacement leafletmaterial.

The polymer or tissue matrix and fiber composite leaflets can then beattached to the stent frame (15) via a variety of methods. Sutures(655), for example can be used to sew the attachment-edge fiber to thestent frame (15) as shown in FIG. 28C. Alternately, the polymer used asthe leaflet film can be used also as a covering (285) for the stentframe; the leaflet can be joined to the stent frame (15) via polymer topolymer bonding methods which include thermal bonding, solvent bonding,adhesive bonding, and other forms of bonding. The leaflet can also becontiguous with the covering (285) that is attached to the stent-valveframe.

Another embodiment for attaching the polymer and fiber compositeleaflets to the stent frame (15) is shown in FIGS. 29A and 29B. In thisembodiment the axial fibers are allowed to extend beyond theattached-edge fiber as shown in FIG. 29A. The axial fiber extensions canthen be attached directly to the stent frame (15) via brazing, welding,swaging, adhesive bonding or other bonding methods available. The axialfibers can alternately be formed to be contiguous with the stent frame.

A thin film (660) of Nitinol or other metal can be cut via laser,electric discharge method (EDM) or other methods to form a leaflet frameas shown in FIG. 30. The leaflet frame can have axial members (665) andcircumferential members (670); the circumferential members can extendalong the free edge forming free-edge members and along the attachededge forming attached-edge members; axial members can extend from thefree-edge members to the attached-edge members. The leaflet frame can beembedded within a polymer matrix as described earlier for the fibersupported leaflet, alternately the leaflet frame can be sandwichedbetween to polymer films via thermal, solvent, adhesive, other bondingmethod used to bond two films together. The leaflet frame can beattached to the stent frame (15) via sutures, adhesive bonding, thermalbonding, welding, brazing, soldering, or other methods. Alternately, theleaflet frame can be contiguously formed along with the stent-valveframe (15).

FIGS. 31A-31D show a surgical replacement valve of prior art with asurgical securement band (865) that can be sewn to the annulus (20) ofthe heart after the native heart valve leaflets (790) have beensurgically removed. Three posts (700) (note: 2-4 posts can alternatelybe used to support 2-4 surgical leaflets (688) respectively) areattached to the surgical securement band (865) and extend downstream(98) to support three surgical leaflets (688). Each post (700) attachesto the commissures (312) of two neighboring leaflets (780). Thereplacement leaflets (270) attach to the posts (700) along acrown-shaped attachment path (275). The leaflet free edges (295) coapttogether forming a leaflet coaptation (710) in a closed configuration asshown in FIGS. 31A and 31B, and the surgical leaflets (688) are shown inan open configuration in FIGS. 31C and 31D with the leaflet free edges(295) forming a circular shape. The posts (700) are impervious to bloodflow across the post wall (720) thereby providing this surgical valvewith an ability to direct blood flow downstream (98) and preventingblood flow upstream (202). The post does not prevent direct contact ofthe native leaflets nor the left ventricular lateral wall frominterfering with the function of the replacement leaflets of atranscatheter mitral valve replacement device.

FIGS. 32A-32D show a prior art transcatheter stent-valve having acylindrically-shaped stent frame (192) that extends from the upstreamend (730) at the nadirs (280) of the leaflet attachments to thestent-valve frame surface (868) to the downstream end (740) at thelocation of the commissures (312) of the replacement leaflets (270). Theleaflet attachment nadir (280) is the location along the crown-shapedattachment path (275) that is tangent or parallel with the upstream end(730) of the stent-valve frame (192). The stent-valve frame (192) canextend further upstream (202) than the nadirs (280) and can extenddownstream (98) further than the commissures (312) without affecting thepresent invention. Three replacement leaflets (270) are attached to thestent frame (192) along a crown-shaped attachment path (275). Theleaflet free edges (295) of neighboring leaflets (780) are coaptedforming a leaflet coaptation (710) in a closed configuration in FIG.32A; the replacement leaflets (270) are in an open configuration in FIG.32B forming a generally circular shape. Each leaflet has a leafletcentral surface (795) that forms a leaflet coaptation (710) withneighboring leaflets (780) near the central axis (45) of the stent-valveframe (192).

Stent-valves used for transcatheter valve replacement have a covering(285) attached to the stent-valve frame (192) in regions extending fromthe upstream end (730) (at the nadir (280) of the leaflet attachment) tothe downstream end (740) of the stent-valve frame (192) (at the locationof the commissures (312) of the replacement leaflets (270). The covering(285) prevents retrograde flow from going from the downstream end (740)to the upstream end (730) when the replacement leaflets (270) are in aclosed configuration and prevents flow from travelling across thesurface of the stent-valve frame wall (750) at locations where thecovering (285) is attached to the stent-valve frame (192); the covering(285) may also assist in preventing perivalvular leaks. The covering(285) can be a thin fabric that lies against the stent-valve frame (192)or it can form an umbrella-like shape, folded shape, or pillow-likeshape, or other skirt-shaped form that can help to prevent perivalvularleak around the outside (880) of the stent-valve frame (192).

The stent-valve frame (192) is formed from a stent structure similar toa vascular stent used in angioplasty; the open stent structure requiresthat the covering (285) be attached to the stent-valve frame (192) toprevent blood flow across the stent wall. When the stent-valve ispositioned such that the downstream end (740) of the stent-valve frame(192) which can form a securement band is secured to a heart annulus(20) as shown in FIG. 32A of the native valve (or other securement ringor location such as the base of native leaflets, for example), astagnation region (760) is created between the native lumen wall (770)or tissue chamber wall (such as the left atrium (80) (LA), for example,for a mitral stent-valve replacement) and the covered stent-valve. Asecurement plane can be formed, for example, which intersects with andis coplanar with the downstream end (740) of the stent-valve frame(192); the downstream end (740) makes contact with the annulus (20)located outside (880) of the stent-valve frame (192) to hold thestent-valve frame (192) via friction, for example, to hold thestent-valve frame (192) from migration and to assist in preventingperivalvular leak due to the covering attached to the stent-valve frame(192). The fluid contained within this stagnation region (760) isrequired to flow in an upstream (202) direction to reach the upstreamend (730) of the stent-valve frame (192) where the fluid can then flowdownstream (98) and flow in an antegrade direction (785) through thelumen of the stent-valve frame (15) and out of the stent-valve with thereplacement leaflets (270) in an open configuration. This stagnationregion (760) can result in the formation of thromboemboli that canmigrate into the blood stream and can lead to the formation of a stroke.

As shown in FIG. 32C, if the stent-valve frame (192) is locatesubstantially within the left atrium (LA) (80) with very little (i.e.,less than 5 mm) or none of the stent-valve frame (192) extending axiallyinto the left ventricle (LV) (165), then a native valve leaflet that isprone to prolapse can overhang or extend into the downstream end (740)of the stent-valve frame (192). The cordae tendineae (177) normallyattach the native leaflet free edges (295) to the papillary muscles(178) to prevent such overhang. However with improper anatomy suchoverhang of the native leaflet can interfere with the function of thereplacement leaflets (270), can block blood flow in a retrogradedirection (805) from initiating closure of the replacement leaflets(270) at the initiation of systole, and can cause regions of stagnationthat can lead to thrombosis and formation of thromboemboli. Extension ofdownstream end (740) of the stent-valve frame (192) into the LV (165) isnecessary to provide contact with the native mitral leaflet and push thenative leaflet (790) outwards (800) such that the native leaflet cannotcause leaflet overhang (810) at the downstream end (740) of thestent-valve frame (192).

The covered stent-valve frame can be located such that a portion of thestent-valve frame (192) that is covered is located above the securementlocation (755) or annulus (20) and a portion of the stent-valve frame(192) is located below the securement location (755) or annulus (20) asshown in FIG. 32D. The amount or volume of stagnation region (760)formed upstream (202) of the securement location (755) is reduced bylocating some of the covered stent-valve downstream of the securementlocation (755). The stagnation region (760) still will allow blood tothrombose and lead to potential formation of thromboemboli. Also, astagnation region (760) exists in the LV (165) between the nativeleaflets (790) and the covered stent-valve region. This stagnationregion (760) can also contribute to thrombosis and formation ofthromboemboli.

The stent-valve component (190) (i.e., second component (190) of the twocomponent system (195) described in earlier embodiments) of the presentinvention is shown in FIGS. 33A-33G. The stent-valve frame (192) canhave a cylindrical shape as shown in FIG. 33A, a frustum shape where theupstream end (730) is of a larger diameter than the downstream end (740)(FIG. 33D), a frustum shape where the upstream end (730) is of a smallerdiameter than the downstream end (740) (FIG. 33E), or other geometricalshape such as shown in FIG. 33F, for example, showing a dual memberstent valve (195) having a larger upstream end diameter (815) and alarger downstream end diameter (820) than the smaller second componentlocking region diameter (845) such as a waist region diameter thatgeometrically fits with a first component locking region diameter (825),for example; the stent-valve frame (192) has an hour-glass shape. Thesmaller diameter waist diameter forms a second component concave waistthat can be used to form a geometric fit or a geometrical lock of thesecond component (190) or stent-valve component (190) of the presentembodiment to the concave waist region (or other geometrical lockingshape) of a first component (200) of the present invention as describedin previous embodiments. Alternately, as shown in FIG. 33H the dualmember stent-valve (195) has the second component (190) or stent-valvecomponent (190) having a convex geometrical region that is able to lockwithin a convex geometrical region found in the first component frame(982).

As shown in FIGS. 33A and 33B, the stent-valve frame (192) has threereplacement leaflets (270) attached to the stent-frame surface (868)along a crown shaped attachment path (275). The present invention canalso include only two replacement leaflets (270) or as many as fourreplacement leaflets (270). The crown-shaped attachment path (275)extends from the upstream end (730) of the stent-valve frame (192) wherethe nadir (280) of the attachment path (275) is in contact with theupstream end (730) of the stent-valve frame (192); the crown-shapedattachment path (275) extends to the leaflet commissures (312) which arelocated at the downstream end (740) of the stent-valve frame (192). Theleaflet attachment nadir (280) is the location along the crown-shapedattachment path (275) that is tangent with the upstream end (730) of thestent-valve frame (192). A leaflet pocket (600) is formed in each of thereplacement leaflets (270) as they each bow inwards at the leaflet nadir(280) at the upstream end (730) of the leaflet; each leaflet forms aleaflet coaptation (710) with other leaflets at the downstream end (740)to block off blood flow toward the upstream end (730) during systole.

The stent-valve frame (192) can extend further upstream (202) than theupstream end (730) and can extend further downstream (98) than thedownstream end (740) of the stent-valve frame (192) if desired. An upperbulb (70), as discussed in other embodiments, can be attached to theupstream end (730) or intermediate between the upstream end (730) anddownstream end (740) of the stent-valve frame (192) to assist theoperator with positioning of the stent-valve frame (192) and assist inblocking perivalvular leaks as described in previous embodiments of thepresent invention. The upper bulb (70) can extend outwards (800) at anangle with respect to the axial direction of the stent-valve frame (192)as described in earlier embodiments. Similarly, a lower bulb, asdiscussed in other embodiments, can be attached to the downstream end(740) or intermediate between the upstream end (730) and downstream end(740) of the stent-valve frame (192) to assist in locking thestent-valve frame (192) onto a securement ring (755). The securementring (755) or securement location (755) can be a native valve annulus(20), native valve leaflets, or a first component (200) that has beenplaced into the heart valve tissues prior to placing the stent-valveframe (192) of this embodiment.

An alternate system for attachment of the second component (190) orstent-valve component (190) to the first component (200) is shown inFIG. 33J. In this embodiment, the torus balloon (35) that is attached tothe first component (200) is inflated with an inflation medium that isretained within the torus balloon (35) by a one-way flapper valve (540)(as shown earlier in FIG. 14, for example) located in the torus balloon(35) that prohibits exit of the inflation medium from the balloon. Theinflation medium can include, for example, saline, polymer gels, curablepolymers that form a solid or crosslinked structure, or other inflationmedium examples. The torus balloon (35) forms a ring that extends inward(928) towards the central lumen (265) of the first component (200). Theinflated torus balloon (35) forms a first component (200) locking regionwith a geometrical shape or first component concave region (211) thatwill lock with a second component stent-valve locking region having asecond component concave locking region (206). The locking of the torusballoon (35) with the second component (190) concave region (206) viageometrical matching shape will prevent the second component (190) orstent-valve component (190) from migrating toward the LA (80) or towardthe LV and will also assist in forming a leak-tight seal between thestent-valve component (190) and the torus balloon (35). The firstcomponent (200) locking region diameter (855) is larger than the secondcomponent cylindrical diameter (860) and matches the second componentlocking region diameter (845) such that a geometrical system lock (842)is formed.

As shown in FIGS. 33F, 33H, and 33J the concave region, convex region,or torus balloon (35) can extend inwards (928) in some embodimentstoward the central lumen (265) of the first component (200) to form afirst component locking region diameter (855) that ranges from 25-35 mm.Other portions of the first component (200) such as the first componentdownstream end (740) are able to extend outwards (800) to make contactwith the mitral valve annulus (20) which can have diameters ranging from30 to over 50 mm. Thus the second component (190) can have a secondcomponent locking region diameter (845) of approximately 25-35 mm to fitsnugly against the locking region diameter (855) of first component(200). The number of sizes for the second component (190) to accommodatethe varying diameters for the mitral valve annulus (20) can thereby bereduced to two or three sizes and thereby reduce device cost andcomplexity.

The replacement leaflets (270) have a bowed leaflet surface that forms aleaflet pocket (600) (as described earlier) that serves to allow bloodflow to enter the leaflet pocket and assist in closure and coaptation ofone leaflet with a neighboring leaflet. The free edges (295) of theleaflets (270) coapt forming a leaflet coaptation (710) when theleaflets (270) are in a closed configuration that prevents retrogradeflow as shown in FIGS. 33A and 33B. During antegrade flow the leaflets(270) are in an open configuration as shown in FIG. 33C; the leafletfree edges (295) are near or in contact with the stent-valve frame (192)at the downstream end (740) of the stent-valve frame (192). FIG. 33Gshows the three leaflets (270) splayed out and lying approximately flatas the leaflet pocket (600) is allowed to form an approximatelyflattened shape. The leaflet has a crown-shaped attachment path (275)that extends from the nadirs (280) to the commissures (312). The leafletfree edges (295) have central coaptation regions that come close or comeinto contact with other central coaptation regions located on otherleaflets (270). Each of the three leaflets (270) can be individualentities that are attached separately to the stent-valve frame (192) ifdesired or they can be formed from a single sheet of tissue material,for example.

As shown in FIG. 33H is a two component system (195) of the presentinvention. The first component (200) is held to the surrounding tissuesor annulus (20) via barb tips (255) that extend into the tissue. Thesecond component (190) has a second component convex region (835) thatlocks into the first component convex region (840) via forming matchinggeometrical shapes that lock together forming a system lock (842) thatholds the first component (190) via friction or geometrical fit. Thesecond component locking region diameter (845) is larger than the firstcomponent cylindrical diameter (850) and matching the first componentlocking region diameter (855) at a location axially adjacent to thefirst component locking region.

FIGS. 34A-34C show embodiments of the present invention having asecurement band (865) of the stent-valve frame (192) that forms anattachment to a securement ring (755); the securement ring (755) can bea native valve annulus (20), for example, for a single component system,or can be a stent-like structure found in a first component (200) of astent-valve system; the securement ring (755) can be a limiting cable(225), for example, found attached to the first component (200) as shownin other embodiments. The securement band (865) is a portion of thestent-valve frame (192) that extends around the perimeter of thestent-valve frame (192) and is adapted to make sealing contact with thesecurement ring (755) and form a frictional or geometrical fit with thesecurement ring (755) and the securement band (865); the securement band(865) can be located at or near the upstream end (730) of thestent-valve frame (192) as shown in FIG. 34A, located at or near thedownstream end (740) of the stent-valve frame (192) as shown in FIG.34B, or located intermediate between the upstream end (730) and thedownstream end (740) of the stent-valve frame (192) as shown in FIG.34C. As shown in FIG. 34C the stent-valve frame (192) and thereplacement leaflets (270) straddle the securement band (865) extendingboth upstream and downstream of the securement band (865). Thesecurement band (865) extends around the perimeter of the stent-valveframe (192) making frictional or geometrical contact with a securementring (755); the securement ring (755) can contain the annulus (20) orother structure of the first component that can serve as a continuousring. A securement plane that contains the securement band (865) canalso contains the structural elements that are placed into appositionwith the securement band; the securement band (865) is held securely tothe securement ring (755) via frictional fit or geometrical fit toprevent the first component (200) from migrational movement and providea seal with the securement ring (755) that prevents fluid leakagebetween the securement band (865) and the securement ring (755). Suchstructural elements for the securement ring (755) can include the nativeannulus (20) or a fixed ring of the first component (200) such as thelimiting cable, for example, as described earlier. The securement band(865) is contained within the securement plane that is perpendicular tothe central axis (45) of the stent valve frame (192).

Referring to FIG. 34A, the securement band (865) of stent-valve frame(192) is placed into contact with the securement ring (755) such as thenative valve annulus (20) or a closed ring (such as the limiting cable(225)) of a first component (200) that is placed into the native hearttissue prior to placing the stent-valve frame (192) (the stent-valveframe and replacement leaflets (270) being equivalent to a secondcomponent (190)) of the present embodiment); the closed ring can beanother member that is attached to the native heart valve tissues suchas a closed ring of an existing mechanical heart valve, for example. Thesecurement band (865) is a portion of the stent-valve frame (192) thatis expanded into contact, sutured into contact, forms a friction fit,forms a geometrical fit, or forms any form of locking fit, or isotherwise attached to the securement ring (755). The securement band(865) can be formed by expanding a portion of the stent-valve frame(192) into contact with the native valve annulus (20) or into contactwith the closed ring of a first component (200), for example. Thesecurement band (865) can be a SE stent region or a BE region of thestent-valve frame (192) that forms a contact with the surrounding nativetissue or contact with an element of a first component (200) (i.e., thefirst component (200) being implanted prior to placement of thestent-valve second component (190) of the present embodiment) and formsa resistance to fluid flow or a blockage for leakage of blood or fluidaround the stent-valve frame (192) between the stent-valve frame (192)and the surrounding tissues or between the stent-valve frame (192) andthe first component (200) member.

The replacement leaflets (270) are attached to the stent-valve frame(192), as described earlier along a crown-shaped attachment path (275)that extends from the nadir (280) located at or near the upstream end(730) to the leaflet commissures (312) located at or near the downstreamend (740) of the stent-valve frame (192). It is noted, that alternatelythe stent-valve frame (192) can extend upstream (202) from the nadirs(280) and can extend downstream (98) from the commissures (312) andremain within the scope of the present invention. The leaflet attachmentnadir (280) is the location along the crown-shaped attachment path (275)that is tangent or parallel with the upstream end (730) of thestent-valve frame (192). The commissures (312) identify the junction ofthe leaflet with the downstream end (740) of the stent-valve frame (192)and also identify a contact point for one leaflet with a neighboringleaflet along the downstream end (740) of the stent-valve frame (192).To prevent leakage of fluid through the stent-valve frame wall (750) ina retrograde direction (805), the region of the stent-valve framesurface (868) located from the nadir (280) of one leaflet to the nadir(280) of a neighboring leaflet at the upstream end (730) and extendingdownstream (98) to the commissures (312) made between those two leaflets(270) is formed with a closed inter-leaflet frame surface (870); theclosed inter-leaflet frame surface (870) extends between two neighboringattachment path portions (910) of the crown-shaped attachment paths(275) of two neighboring leaflets (780). A closed surface (875) does notallow fluid flow across the wall of the stent-valve frame wall (750)from inside (878) to outside (880) of the stent-valve frame (192). Acovering (285) attached to the stent-valve frame (192) can be used toform a closed surface (875). This closed surface (875) will be referredto as the closed inter-leaflet frame surface (870) since it is locatedon the frame surface (868) and is located between two neighboringleaflets (780); this closed surface (875) will be referred to as aclosed downsteam-planar inter-leaflet frame surface (872) since theclosed surface (875) shown in this embodiment is located downstream (98)of the securement plane (755); hence in this embodiment zero percent ofthe second component frame (192) extends into the LA (80). The closedinter-leaflet frame surface (870) is similar to the posts (700)described earlier for the surgical valve and which prevents fluid flowacross the surgical valve posts (700).

The stent-valve frame surface (868) located between the crown-shapedattachment path (275) of a single replacement leaflet from thatleaflet's nadir (280) to the downsteam end of the stent-valve frame(192) is formed from an open mesh stent frame (similar to a vascularstent without a covering) that provides passage of blood or fluid acrossthe stent-valve frame wall (750) and is hence referred to as an opensurface (885). This open surface (885) portion of the stent-valve framesurface (868) will be referred to as an open downsteam-planarintra-leaflet frame surface (890) since it is located adjacent to andradially outward from a single valve leaflet and is located along thestent-valve frame surface (868). The open downstream-planarintra-leaflet frame surface (890) allows direct access of blood in theLV (165) between the native leaflet and the stent-valve frame (192);blood will flow radially outwards through this open surface (885) andimpact directly onto the native tissues surrounding the stent-valveframe (192) thereby reducing the opportunity for a stagnation region(760) of blood in the LV (165) between the native leaflets (790) and thestent-valve frame (192) and thereby removing the potential for harmfulthromboemboli formation and release to the brain. The opendownstream-planar intra-leaflet surface also allows a small amount ofblood to flow in a retrograde direction (805) across the atrial surfaceof the native leaflet tissue at the initiation of systole and radiallyinwards from the native tissue surrounding the stent-valve frame (192)to the inside (878) of the stent-valve frame (192) to help close thereplacement leaflets (270). The open downstream-planar intra-leafletsurface also prevents leaflet overhang of the native leaflets frominterfering with the function of the replacement leaflets.

As shown in FIG. 34A the leaflet free edges (295) are shown in a closedconfiguration. This embodiment will not allow retrograde flow occur fromthe downstream end (740) to the upstream end (730) as long as thesecurement band (865) is able to form a leak-free seal with thesecurement ring (755) via frictional fit due to the outwards expansionforces of the first component (200) or via a geometrical fit between thefirst component (200) and the second component (190). The closedinter-leaflet frame surface (870) can be formed by attaching a polymericfilm, a polymeric weave, or other fabric to the stent-valve frame (192)at a location between neighboring leaflets (780) and extending to thecommon commissure for the two neighboring leaflets (780) as describedfor the closed inter-leaflet frame surface (870). The attachment of thefabric to the stent-valve frame (192) can be via adhesives, suturing,thermal bonding, solvent bonding, polymer bonding or any other methodthat achieves a seal that prevents fluid leakage across the stent-valveframe wall (750). Thus the inter-leaflet frame surface below thesecurement band (865) is a closed inter-leaflet frame surface (870) andthe intra-leaflet frame surface below the securement band (865) is anopen intra-leaflet frame surface. Any of the intra-leaflet framesurfaces that extend above the securement plane (758) (as described infurther embodiments) would be required to be closed frame surfaces(875). In some instances the fabric located along the closed surface ofthe stent-valve frame (192) can be contiguous with or attached to thereplacement leaflet material along the crown shaped attachment path ofthe replacement leaflet extending from the leaflet nadir to the leafletcommissures.

The open downstream-planar intra-leaflet frame surface (890) can beformed from a stent-like structure without a covering (285) that allowsblood to travel through the stent-valve frame wall (750). The openintra-leaflet frame surface can make contact with the native leaflets(790) and serve to hold the native leaflets (790) outwards (800) suchthat the native leaflets (790) cannot make contact with the replacementleaflets (270) or overhang the downstream end (740) of the stent-valve.Also, blood can flow freely through the open frame surface (885) of thestent-like structure of the stent-valve frame (192). Alternately, theopen downstream-planar intra-leaflet frame structure can be completelyeliminated or removed forming a completely open surface (900) such thatblood flow through this open region does not make contact with anystent-like structure.

FIG. 34B shows an embodiment of the present invention that allows thestent-valve frame (192) from the upstream end (730) to the downstreamend (740) to be located, for example, in the LA (80) and having thesecurement of the stent-valve frame (192) located near or at thedownstream end (740) of the stent-valve frame (192) to the securementring (755) such as a heart annulus (20) or a region of a first component(200) (of a two component stent-valve system, for example) that isimplanted prior to placing the stent-valve frame (192) of the presentembodiment as a second component (190), for example. In this embodiment100% of the stent-valve frame length (941) extends into the LA (80) andzero percent extends into the LV (165). Locating the stent-valve frame(192) such that up to 85% (range 15-85%) of the second component framelength (941) extends into the left atrium will ensure that impingementof the stent-valve frame (192) onto the native anterior mitral valveleaflet or onto the left ventricular outflow tract does not occur, butstill the stent-valve frame (192) will prevent overhang of the nativeleaflets onto the replacement leaflets (270).

In this embodiment the closed surface (875) of the stent-valve frame(192) is located within the boundaries formed by the crown-shapedattachment path (275) of a single replacement leaflet (270) to thestent-valve frame (192) from a leaflet nadir (280) to the downstream end(740) of the stent-valve frame (192) and extending from one commissureof that leaflet to the other commissure of that leaflet. This closedsurface (875) will be referred to as the closed intra-leaflet framesurface (915) since the surface is located on the frame surface (868)and is adjacent to and located radially outward (800) from a singleleaflet. For a stent-valve having three replacement leaflets (270), forexample, there will be three closed upstream-planar intra-leaflet framesurfaces (920) as shown in FIG. 34B. The frame surface upstream (202) ofthe securement band (865) and located between the attachments of twoneighboring leaflets (780) (i.e., the open upstream-planar inter-leafletframe surface (922)) is an open surface (885); this open frame surface(885) extends between two neighboring attachment path portions (910) ofthe crown-shaped attachment path (275) of two neighboring leaflets(780). The attachment path portions extend from the nadir (280) of aleaflet to the securement band (865). An open frame surface (885) allowsblood or fluid to travel freely across the stent-valve wall from outside(880) to inside (878), for example, from the chamber of the LA into thestent-valve. The open upstream-planar inter-leaflet frame surface (922)is an open frame surface (885) formed, for example, of an open strutstructure found in vascular stent without a covering (285) that allowsfor fluid flow across the open strut structure of the stent frame (192).As fluid attempts to flow in a retrograde direction (805) with the valveleaflets (270) in an closed configuration, the closed upstream-planarintra-leaflet frame surface (920) will prevent blood or fluid fromtravelling in a retrograde direction (805) from the downstream end (740)and out of the upstream end (730) of the stent-valve frame (192) orthrough the stent-valve frame wall (750) as the retrograde fluid istrapped in the three pockets formed by the native leaflets and theclosed upstream-planar intra-leaflet frame surface (920).

The upstream-planar inter-leaflet frame structure (925) can be formedfrom a stent-like structure without a covering (285) that allows bloodto pass freely through the stent-valve wall without measurableresistance to blood flow. Alternately, the upstream-planar frame surface(925) can be formed by providing a completely open surface (900) thatdoes not contain any stent-like frame structure at all and thestent-valve frame (192) has been eliminated in this region having acompletely open surface (900).

The open upstream-planar inter-leaflet frame surface (922) locatedupstream (202) to the securement band (865) provides an open surface(885) or completely open surface (900) for blood or fluid to flow in anantegrade direction (785) or inward direction (928) across thestent-valve frame wall (750) and through the open replacement leaflets(270) and downstream (98) from the downstream end (740) of thestent-valve frame (192). This open upstream-planar inter-leaflet framesurface (922) located above the securement plane (758) will provide adirect path for blood flow or fluid flow in an antegrade or lateraldirection from a region above the securement plane (758) across thestent-valve wall without generating a stagnation region (760) caused byexisting covered stent-valves. Existing covered stent valves requireblood or fluid located between the native chamber and the stent valveabove the securement plane (758) or securement band (865) to flow in aretrograde direction (805) in order to enter into the upstream end (730)of a covered stent-valve frame (192). The three pockets formed by thereplacement leaflets and the closed upstream-planar intra-leaflet framesurface can be formed by attaching the replacement leaflet to thecovering that is located along the closed surface areas of thestent-valve frame (192); the attachment extending along the crown shapedleaflet attachment path (275) (see FIG. 34). The formation of suchpockets can allow the elimination of the stent frame structure entirelyfrom a portion of the stent-valve frame (192) located upstream of thesecurement band thereby reducing the profile of the second component(190). The presence of a stent frame upstream of the securement bandprovides structural stability to the replacement leaflets to preventleaflet deformation during antegrade blood flow.

FIG. 34C shows an embodiment having the securement plane (758) orsecurement band (865) located intermediate between the upstream end(730) and the downstream end (740) of the stent-valve frame (192). Inthis embodiment, the stent-valve frame (192) can be extended less intothe LV (165) and more into the LA (80) for those patients that have anLVOT anatomy that would not tolerate potential obstruction of the LVOTcaused by placing 1-2 cm of stent-valve stent axial length adjacent tothe native mitral anterior leaflet and pushing the leaflet towards theLVOT. The portion of the frame surface (868) located upstream (202) ofthe securement band (865) or securement plane (758) will be referred toas the upstream-planar frame portion (930) and is attached to anupstream-planar leaflet portion (929) and the portion of the framesurface (868) located downsteam of the securement plane (758) orsecurement band (865) and is attached to a downstream-planar leafletportion (931) will be referred to as the downstream-planar frame portion(932). In this embodiment the intra-leaflet frame surface (i.e., theframe surface located between the crown-shaped attachment of a singleleaflet) located above the securement plane (758) is a closedupstream-planar intra-leaflet frame surface (920), and does not allowfluid to pass through the stent-valve frame wall (750); this surface isa closed upstream-planar intra-leaflet frame surface (920).

In one embodiment the closed upstream-planar intra-leaflet frame surface(920) has a covering (285) attached to the frame surface at a locationradially adjacent and outwards from the replacement leaflets andfollowing along the crown-shaped leaflet attachment path (275) and isattached to the stent-valve frame (192). In an alternate embodiment aportion of the stent-valve frame (192) can be eliminated or absent fromthe upstream-planar frame surface upstream of the securement band (865).A leaflet pocket (600) can be formed by attaching a fabric to thereplacement leaflet (270) along the crown-shaped portion of thereplacement leaflet (270) that extends from the leaflet nadir (280) toeach of the commissures (312) for the replacement leaflet (270). It isnoted however, that the presence of a frame structure in theupstream-planar frame structure region will provide strength andstructural integrity to the replacement leaflet along the leafletattachment path (275) and will prevent the replacement leaflet (270)from deforming improperly during antegrade flow and provide structuralstrength to the replacement leaflet during retrograde blood flow.

The downstream-planar intra-leaflet frame surface (935) (i.e., the framesurface located between the crown-shaped attachment of a single leaflet)located downsteam of the securement plane (758) is an open frame surface(885) (as shown in FIG. 34C) that allows fluid to pass through thestent-valve frame wall (750) radially outwards and into direct contactwith the native tissues that surround the stent-valve frame (192); thisdownstream-planar intra-leaflet frame surface (935) as shown in FIG. 34Cis an open downstream-planar intra-leaflet frame surface (890) sincefluid can pass freely across the stent-valve frame surface orstent-valve frame wall (750) in this region. This open downstream-planarintra-leaflet frame surface (890) allows direct blood flow to enter intothe stent-valve via a radially inward direction between the nativeleaflets (790) and the stent-valve without requiring blood entrance fromthe downstream end (740) of the stent-valve during the initiation ofventricular contraction at the beginning of systole. Thus, bloodstagnation regions (760) between the native leaflets (790) and thestent-valve frame (192) are minimized. Additionally, during antegradeblood flow through the stent-valve during diastole or LV (165)relaxation, blood can exit radially outwards through the opendownstream-planar intra-leaflet frame surface (890) and impinge directlyonto surrounding tissues with a radial direction that will ensure thatstagnation between the native leaflets (790) and the stent-valve frame(192) is minimized.

It is noted that this open downstream-planar intra-leaflet frame surface(890) can, in an alternate embodiment, be a closed frame surface (875)(i.e., a closed downstream-planar intra-leaflet frame surface) if it isdesired or more easily manufactured with a covering (285), for example;the stent-valve will still function to direct antegrade flow from theupstream end (730) to the downstream end (740) and will block retrogradeflow from the downstream end (740) to the upstream end (730) of thestent-valve. A closed downstream-planar intra-leaflet frame surfacewould not provide the advantage (to reduce stagnation between the nativeleaflets and the stent-valve frame) described above for the opendownstream-planar intra-leaflet frame surface (890).

In the embodiment of FIG. 34C the open upstream-planar inter-leafletframe surface (922) upstream (202) of the securement plane (758) (i.e.,the frame surface located between the crown-shaped attachment of twoneighboring leaflets (780) and extending from the nadirs (280) of thosetwo neighboring leaflets (780) to the securement band (865)) is an openframe surface (885) that allows fluid to pass freely through thestent-valve frame wall (750); this open frame surface (885) is referredto as the open upstream-planar inter-leaflet frame surface (922). Thenadirs (280) of the replacement leaflets are located at the upstream endof the stent-valve frame to provide the stent-valve frame (192) with theshortest axial length possible and thereby provide an enhancedcapability for the stent-valve frame (192) to be delivered viatranscatheter delivery across the atrial septum and bend with thesmallest radius of curvature to allow such delivery. The openupstream-planar inter-leaflet frame surface (922) is contained betweenneighboring attachment path portions (910) of the crown-shapedattachment path (275) of two neighboring leaflets (780). It is this openupstream-planar inter-leaflet frame surface (922) that allows blood orfluid to enter the stent-valve across the stent-valve frame wall (750)upstream (202) of the securement band (865) in an antegrade and aninward direction (928) without generating a stagnation region (760) asfound in existing prior art devices. Existing prior art devices requirethe blood or fluid to undergo a retrograde directionality (805) of flowto enter into the upstream end (730) of the stent-valve frame (192)thereby resulting in fluid stagnation and leading to potential formationof thromboemboli.

The closed downstream-planar inter-leaflet frame surface (872)downstream (98) of the securement band (865) (i.e., the frame surfacelocated between neighboring attachment path portions (910) of thecrown-shaped attachment of two neighboring leaflets (780) and extendingfrom the securement band (865) to the commissures (312) of those twoneighboring leaflets (780) located at the downstream end (740) of theframe) is a close frame surface that prevents fluid from passing throughthe stent-valve frame wall (750); this closed frame surface (875) isreferred to as the closed downstream-planar inter-leaflet frame surface(872). It is the closed upstream-planar intra-leaflet frame surface(920) and the closed downstream-planar inter-leaflet frame surface (872)that prevents retrograde blood or fluid to pass across the stent-valveframe wall (750) with the leaflets (270) in a closed configuration; thisstent-valve structure allows the stent-valve of the present invention tofunction to direct blood flow in an antegrade direction (785) andprohibit blood flow in a retrograde direction (805).

It is noted that the open frame surfaces (885) of this embodiment can beformed from an open stent-like structure without a covering (285) thatallow blood to pass through the stent frame wall (750). Alternately, theopen frame surface (885) found either upstream-planar ordownstream-planar can be formed without any stent frame structure inthese open surface regions and thereby form a completely open surface(900) as presented earlier. For the case where the device is used totreat a patient having native leaflet prolapse, the presence of an openframe surface (885) but still having a frame present along the entireperimeter of the frame that extends into the LV but no covering alongthe entire perimeter of the frame that extends into the LV will prohibitimpingement of the native leaflet onto the downstream end (740) of thestent-valve and prevent native leaflet overhang (810) at the locationnear the downstream end (740) of the stent-valve.

The stent-valve frame portion that extends into the LA can be formedwith a cylindrical shape, a frustum shape, or other curved shape, ifdesired. The frustum shape as described in FIGS. 33D-33F can be of asmaller diameter at its upstream end to prevent contact of the upstreamend with the wall of the LA. Alternately the stent-valve frame can havethe larger diameter of a frustum located at the upstream end of thestent-valve frame (192) to assist with placement and locking of thestent-valve frame (192) into the securement ring (755). The structuralelements of the stent-valve frame (192) and replacement leaflets (270)described in FIGS. 34A-34H can be equally applied to other embodimentsof the present invention.

FIGS. 34D-34F show embodiments of dual member stent-valve (195)positioned with various depths of the second component (190) extendinginto the LV. FIG. 34D shows the second component (190) or stent-valvecomponent (190) of the present invention located within the centrallumen (265) of a first component (200) that has been attached to themitral valve annulus (20). The second component (190) is positioned suchthat the downstream-planar frame portion (932) is located within the LV(165) and is in contact with the native valve leaflets (790) pushingthem outwards (800) such that the native leaflets (790) are not allowedto prolapse or overhang the downstream end (740) of the stent-valve. Thedownstream-planar frame length (938) extending downstream (98) from thesecurement band (865) to the commissures (312) is 7-15 mm. Theupstream-planar frame portion (930) has an upstream-planar frame length(940) extending upstream (202) from the securement band (865) to thenadirs (280) that is 7-15 mm. In this embodiment that straddles themitral annulus (20) or securement plane (758) at least 35% of the secondcomponent frame length (941) (range 35-65%) extends into the LA. Thedownstream planar frame portion (938) ranges from 35-65% of the secondcomponent frame length (941). This embodiment which straddles the mitralannulus (20) provides a balance of a short downstream-planar framelength (938) that will not contribute to LVOT obstruction and will notimpact upon the wall of the LA which can lead to the formation of atrialfibrillation, and the downstream-planar frame length (938) will prohibitoverhang of the native leaflets (790) into contact with the replacementleaflet function and can interfere with blood flow across the downstreamend (740) of the stent-valve frame (192).

FIG. 34E shows the second component (190) of the present inventionlocated within the central lumen (265) of a first component (200) thathas been attached to the mitral valve annulus (20). The second component(190) is positioned such that the downstream-planar frame portion (932)is located within the LV (165) and is in contact with the native valveleaflets (790); the downstream-planar frame portion (932) has adownstream planar frame length (938) that is at least 15% (range 15-55%)of the second component frame length (941) and at least 45% of thesecond component frame length (941) extends into the LA (i.e., thedownstream planar frame portion ranges from 15-55% of the secondcomponent frame length (941)) may push the native leaflets (790)outwards (800) with less outward displacement than that shown in FIG.34D; some native leaflet prolapse can occur, and the native leaflets(790) may be able to overhang the downstream end (740) of thestent-valve to a lesser extent than that shown in FIG. 34B. Thedownstream-planar frame length (938) extending downstream (98) from theattachment band to the commissures (312) is 5-8 mm. The upstream-planarframe length (940) extending upstream (202) from the attachment band tothe nadirs (280) is 12-18 mm. The greater upstream-planar length (i.e.,greater than that shown and described for FIG. 34D) can causeimpingement of the stent-valve frame (192) upon the wall of the LA (80)resulting in potential for formation of atrial fibrillation.

FIG. 34F shows the second component (190) of the present inventionlocated within the central lumen (265) of a first component (200) thathas been attached to the mitral valve annulus (20). The second component(190) is positioned such that the upstream-planar frame portion (930) islocated primarily within the LA. The percentage of the stent-valvecomponent frame (192) that extends into the LV (165) can be zeropercent. Little contact is made between the downstream-planar frameportion (932) of the stent-valve frame (192) with the native valveleaflets (790) thereby allowing the native leaflet to prolapse oroverhang the downstream end (740) of the stent-valve. Thedownstream-planar frame length (938) extending downstream (98) from theattachment band to the commissures (312) is 0-5 mm. The upstream-planarframe length (940) extending upstream (202) from the attachment band tothe nadirs (280) is 15-22 mm.

FIG. 34G shows the second component (190) having a securement band (865)located downstream (98) of the replacement leaflet commissures (312). Asshown, the second component concave region (206) is intended to beplaced adjacent to a securement ring or a valve annulus. It isunderstood that a second component convex region or other geometricallocking shape can be used to form a geometrical lock or frictional lockwith the securement ring or limiting cable of the first component. Thesecurement band (865) has a covering (285) attached to its surfacearound its perimeter. The covering may extend to the overlap band-ringregion (948) to ensure that leakage of blood cannot occur near thejunction of the commissures (312) and the securement band (865). In thisembodiment, the replacement leaflets (270) are located entirely withinthe LA.

FIG. 34H shows a second component (190) having a securement band locateddownstream of the replacement leaflet commissures (312) similar to thatshown in FIG. 34G. The securement band is intended to geometrically orfrictionally lock with the securement ring or limiting cable of thefirst component. A downstream-planar frame portion (932) has a downsteamframe enlargement (933) that provides a larger downstream frame diameter(934) than the second component locking region diameter (845). Thelarger downstream frame diameter (934) is able to make contact with thenative leaflets below the native leaflet rim to assist in preventingupstream migration of the second component and also thereby preventingmigration of the first component to which the second component hasformed a geometrical lock. In this embodiment, the replacement leaflets(270) are located entirely within the LA.

The securement plane (758) can be the planar region, saddle-shapedregion, or D-shaped region, or round region, or oval region thatcontains a securement ring (755) and intersects to make contact with thesecurement band (865) of the stent-valve frame (192), for example. Thesecurement ring (755) can be a closed ring of a first component (200)member that is delivered prior to the second component (190) that isdescribed in the present embodiment, for example, to which thestent-valve frame (192) is being secured as shown in FIGS. 35A and 35B.A securement band (865) located on the stent-valve surface extends alongthe perimeter of the stent-valve frame surface such that the securementband (865) is perpendicular to the central axis (45) of the stent-valveframe (192). The securement band (865) forms a tight seal with thesecurement ring (755) such that fluid cannot leak between the outside(880) of the stent-valve frame (192) and the securement ring (755)associated with the native tissue (or a first component (200), forexample) outside (880) of the stent-valve frame (192). The securementband (865) has a securement band height (942) in the axial direction ofthe stent-valve. This securement band height (942) can range from lessthan 1 mm to over 10 mm. The securement band (865) has a securement bandheight (942) that allows for an overlap band-ring region (948) for aclosed frame surface (875) to extend upstream (202) or downstream (98)beyond the securement plane (758) and thereby ensure a leak-free sealacross the frame surface near the securement plane (758) and assists inpreventing fluid leakage between the stent-valve frame surface and thesurrounding tissues or an initially placed first component (200). Asshown in FIG. 35B, the stent-valve frame (192) has the securement band(865) between the upstream end (730) and the downstream end (740), forexample; a portion of the upstream-planar inter-leaflet frame surface(945) located above the securement band (865) (also see FIG. 34C) can becovered with a covering (285) which includes the securement band (865)that prevents flow across the stent-valve frame wall (750) in order toimprove the seal that is made between the securement band (865) and thesecurement ring (755). As shown in FIG. 35A, a securement band (865)having a securement band height (942) is secured to the securement ring(755); the securement band (865) is located near the downstream end(740) of the stent-valve frame (192). The securement band height (942)provides a securement band-ring overlap that assists in preventingleakage of fluid between the stent-valve frame (192) and the surroundingtissues (or first component (200)) and preventing fluid leakage acrossthe stent-valve frame (192) in a region that is intended to have aclosed stent-valve surface.

It is further understood that in some embodiments the covered surface ofthe stent-frame can extend beyond the specific crown-shaped attachmentpath (275), if desired, to ensure that a tight seal is made, forexample, between a closed surface (875) and a replacement leaflet, forexample, or a closed surface (875) and a securement band (865), forexample.

FIGS. 36A and 36B show a stent-valve frame (192) with the downstream end(740) located adjacent to the securement ring (755); the securement band(865) is aligned with the securement ring (755). FIG. 36A shows howblocked fluid flow (950) is blocked from crossing over the stent-valveframe surface by having a closed upstream-planar intra-leaflet framesurface (920). In FIG. 36A the replacement valve leaflets (270) are in aclosed configuration and blood flow in a retrograde direction (805) isbeing stopped by the closed leaflets (270) and by the closedupstream-planar intra-leaflet frame surface (920). In FIG. 36B the valveleaflets (270) are open and antegrade fluid flow (952) in an antegradedirection (785); inward fluid flow (955) traveling radially inward (928)is allowed to travel across the open upstream-planar inter-leaflet framesurface (922) and into the central lumen (265) of the stent-valve andflow downstream (98) from the downstream end (740) of the stent-valve.

FIGS. 37A-37B show the stent-valve frame (192) positioned such that thesecurement band (865) is located intermediate from the upstream end(730) and the downstream end (740) of the stent-valve frame (192). FIG.37A shows the leaflets (270) in a closed configuration and retrogradeblood flow is blocked from crossing the stent-valve frame surface at theinitiation of systole by the closed upstream-planar intra-leaflet framesurface (920). The closed downstream-planar inter-leaflet frame surface(872) prevents fluid flow from passing from inside (878) to outside(880) across the stent-valve frame surface. The open downstream-planarintra-leaflet frame surface (890) allows initial systolic blood flow(960) to travel inwards (928) and in a retrograde direction (805) at theinitiation of systole to assist in closing the replacement leaflets(270) and also to provide blood flow between the native leaflets (790)and the stent-valve frame (192) to minimize blood stagnation and preventthe formation of thromboemboli. The leaflet central surface (795) thatforms a pocket extends to the central coaptation site (958).

FIG. 37B shows the replacement leaflets (270) in an open configuration.Blood flow in an antegrade direction (785) and inward fluid flow (955)occurs through the open upstream-planar inter-leaflet frame surface(922) from outside (880) the stent-valve to inside (878) the stent-valveand extends downstream (98) from the downstream end (740) of thestent-valve. As the antegrade blood flow travels downstream (98) of thesecurement band (865), the antegrade blood flow can travel in a radiallyoutward direction (800) and exit through the open downstream-planarintra-leaflet frame surface (890); this blood flow will travel radiallyoutwards from the stent-valve frame (192) and impinge directly onto thenative tissues such as the native leaflets (790) ensuring that bloodstagnation does not occur in the LV (165) between the stent-valve frame(192) and the native leaflets (790).

FIGS. 38A and 38B show an embodiment for the first component (200) ofthe stent-valve system of the present invention; much of this embodimenthas been described in previous embodiments. The first component frame(982) is positioned such that the barbs (25) of the first component(200) penetrate into the mitral annulus (20), for example. As the barbs(25) are activated, they penetrate through the covering (285) and extendinto the surrounding tissues. It is noted that the covering (285) forthe first component frame (982) can be located inside (878) of thebarbs)25) such that the barbs (25) can extend outwards upon activationwithout interacting with or penetrating through the covering (285). Thefirst component frame distal end (965) is in contact with the nativeleaflet shoulder (962) of the native mitral valve leaflets (790) toprovide for ease of positioning of the first component (200). Theleaflet shoulder (962) is transition corner of the native leaflet rim(977) where the native leaflet (790) curves from the plane of theannulus toward the LV; the leaflet rim (977) being the continuousportion of the native leaflet that extends around and attaches to theperimeter of the annulus having net yet formed individual nativeanterior and posterior mitral leaflets. The native mitral valve leaflets(790) are able to function normally while the first component (200) isbeing delivered such that the fixation ring (986) of the first component(200) is adjacent to the mitral annulus (20). The first component (200)proximal end (968) is attached to recapture struts (100) (shown in FIG.38A) that contain a holding feature (110) such as a ring located at theupstream end (730) of the recapture struts (100); control fibers (120)can form a loop through the rings; the control fibers (120) then extendinto the delivery sheath (105). The control fibers (120) allow the firstcomponent (200) to be held, repositioned, or retracted into the deliverysheath (105) prior to activation of the barbs (25) as described inearlier embodiments. Upon determination that the first component (200)is located properly, the torus balloon (35) is inflated with saline toactivate the barbs (25) outward into the mitral annulus (20) upstream(202) and adjacent to or touching the native mitral valve leaflets(790). A backing element (450) can be located to the inside (878) of thetorus balloon (35) to ensure that the inflation forces of the torusballoon (35) cause the barbs (25) to become activated by pushing thebarbs (25) outwards (800). A limiting cable (225) can be located alongthe perimeter of the first component frame (982) to provide a closedring into which a second component (190) (i.e., the stent-valve frame(192) that contains the replacement leaflets (270)) can be expanded andheld via friction fit, geometrical shape fit, or other locking mechanismincluding the locking features as described in earlier embodiments. Thestent limiting cable (225) can be formed and included within the stentconfiguration to limit the stent from expansion beyond a preset amount;the stent limiting cable (225) can serve as a securement ring (755) toform the closed ring structure. A flexible strut or flexible element ofthe stent-like structure of the first component frame can act as alimiting cable (225) by connecting the hinge regions of a zig-zag stentstructure, and prevent the zig-zag structure (335), for example, fromopening beyond a specified perimeter. This flexible strut or cable canbe formed, for example, via a laser machining operation that is used tolaser cut the zig-zag shape of the first component stent frame (982).

FIG. 38B shows one embodiment for a first component frame structure(982) formed with a closed cell structure. The first component frame(982) is shown, for example, with a conical or frustum shape with thesmaller diameter distal end (965) of the frustum being positionedadjacent to the native leaflet shoulder (962). The barbs (25) are shownin an activated configuration after being pushed outwards into themitral annulus via the torus balloon (35). The first component frame(982) could equally well have been configured with an open cellstructure.

FIG. 39A shows a second component frame (192) having a generallyhour-glass shape having a securement band (865) located between theupstream end (730) and the downstream end (740) and having a smallerdiameter waist (205) than the upstream end (730) and the downstream end(740).

The upstream-planar frame portion (930) forms a conical (or frustum)shape that can match the conical shape of the first component framepresented in FIG. 38B and thereby will automatically align the centralaxis (45) of the second component frame (192) with the central axis ofthe first component frame (982) when the two components are broughttogether to form a two-component stent-valve system. The secondcomponent frame (192) can be formed from a closed cell structure asshown in FIG. 39A or can be formed from an open cell structure. Thecrown-shaped attachment (275) of the replacement leaflets (270) follow acrown-shaped pattern of the structural Nitinol struts or elements of thesecond component frame (192). Portions of the surface of the secondcomponent frame (192) can be covered, open, or completely open asdescribed in other embodiments of the present invention.

FIGS. 39B and 39C show the dual member stent-valve (195) ortwo-component stent-valve system having the second component (190) ofthe present invention or stent-valve frame (192) being placed within theinside (878) or central lumen (265) of the first component (200) andheld to the first component via a system lock (842). The system lock(842) can be a friction fit between the first component frame (982) andthe second component frame (192) as shown in FIG. 39B or a geometricalfit as shown in FIG. 39C. The second component (190) is placed such thatthe downstream end (740) of the stent-valve frame (192) is downstream ofthe mitral annulus (20). The securement band (865) is locatedintermediate between the upstream end (730) and the downstream end (740)of the stent-valve frame (192). Placing the second component (190) withan upstream-planar frame portion (930) of the stent-valve frame (192)located in the LA allows an advantage that less of the downstream-planarframe portion (932) of the second component (190) stent-valve frame(192) extends downstream (98) of the securement ring (755) which can bethe limiting cable (225) and securement plane (758); thus thestent-valve frame (192) is less likely to impinge upon the LVOT and lesslikely to push the native leaflets (790) into the LVOT. The openupstream-planar inter-leaflet frame surface (922) allows inward bloodflow (955) from the LA (80) to travel in an antegrade and inwarddirection (928) through the stent-valve frame wall (750). Fluid flow isnot required to flow in a retrograde direction (805) within the LA toenter into the upstream end (730) of the stent-valve frame (192) asfound in existing stent-valve devices that cause stagnation andresultant thromboemboli. Fluid can flow radially outwards out of theopen downstream-planar intra-leaflet frame surface (890) and impingedirectly onto the native tissues such as the native leaflets to washtheir atrial surface and prevent thrombus formation. The stent-valveframe (192) of the second component (190) can lock to the firstcomponent (200) via a friction fit, geometric fit, or other lockingmechanism to hold the first component (200) to the second component(190) via a system lock (842).

The contact of the downstream end (740) of the stent-valve on the nativeleaflets (790) will act to prevent the native leaflets (790) fromoverhanging into the downsteam end of the stent-valve frame (192) whichcould impair replacement leaflet function and can cause stagnationregions (760) leading to thrombus formation. The first component (200)and second component (190) can have concave geometrical structures intheir waists or in other regions (as shown in other embodiments) alongtheir length to assist with locating the first component (200) withinthe second component (190) and locking them together to form a systemlock (842). Alternately, the torus balloon (35) can be inflated not onlyto activate the barbs (25) of the first component (200) but also toserve as a locking ring to which a concave region of the secondcomponent (190) can form a geometrical lock as the SE stent frame of thesecond component (190) expands outwards (800) into contact with thefirst component (200) to form a system lock (842). The downstream-planarframe portion (932) of the stent-valve will help to prevent the nativeleaflets (790) from prolapsing into the replacement stent-valve.

The torus balloon (35) can be inflated with a fluid or gel, for example,that is retained within the torus balloon via a flapper valve; the torusballoon can serve to hold the stent-valve frame (192) of the secondcomponent (190) from migration and also provide a seal that will preventleakage between the first component (200) and the second component (190)as the second component (190) expands outwards into contact with thetorus balloon (35). The inflated torus balloon allows the secondcomponent (190) to require a significantly smaller diameter than thefirst component frame (982) that is located radially adjacent to theannulus (20) and require a smaller number of second component diametricsizes to accommodate the large range of patient annulus diameters. Thetorus balloon (35) of the first component (200) also allows movement ofthe mitral annulus identified from systolic and diastolic motion to beabsorbed by the torus balloon and not transferred to the secondcomponent (190). The second component (190) can thereby retain a moreconsistent shape such as a round shape, for example, due to the abilityof the torus balloon (35) to deform and comply with shape changes thatoccur during contraction and relaxation of the heart and annulus (20).

FIG. 39C shows an embodiment of the first component frame (982) that hasbeen attached to the mitral annulus as presented in FIG. 38B and locatedon the LA side of the native leaflets (790) such that native leafletfunction is not affected. The second component frame (192) has beendelivered within the lumen of the first component frame and releasedsuch that the second component waist (205) is located adjacent to and incontact with the limiting cable (225) of the first component frame(982). The upstream-planar frame portion (930) of the stent-valve frame(192) has a conical shape that fits within the conical shape of thefirst component frame (982) such that the first component frame (982) isaxially aligned with the second component frame (192) due to thecone-in-cone geometrical fit. The second component waist (205) willorient itself in an axial direction (i.e., along the direction of thecentral axis (45)) to be positioned adjacent to the limiting cable (225)which forms a securement ring (755) with a closed ring configuration.The downstream-planar frame portion (932) can push outwards a smallamount onto the native leaflet rim (977) or on the LV side of the nativeleaflet rim (977) to assist in holding the dual-member stent-valve (195)from migrating toward the LA. The downstream planar frame portion (932)should not push the anterior native leaflet towards the LVOT which canobstruct blood flow in the LVOT.

FIG. 40 shows the dual member stent-valve (195) of the present inventionhaving the second component (190) of the present invention being placedwithin the inside (878) or central lumen (265) of the first component(200). The second component (190) is placed such that the downstream end(740) of the stent-valve frame (192) is upstream (202) of the nativemitral valve leaflets (790) thereby placing the securement band (865)near or at the downstream end (740) of the stent-valve frame (192) andadjacent to the securement ring (755), heart annulus (20), or hearttissue. The second component (190) is placed with all or nearly all ofthe stent-valve frame (192) located in the LA (80) with the advantagethat none or almost none of the second component (190) stent-valve frame(192) extends downstream (98) of the securement ring (755) (such as themitral annulus (20), for example). The stent-valve frame (192) cannotimpinge upon the LVOT (155) and cannot push the native leaflets (790)into the LVOT since the stent-valve frame (192) does not extenddownstream (98) beyond the mitral annulus (20), for example. The openupstream-planar inter-leaflet frame surface (922) allows antegrade bloodflow (952) or inward blood flow (955) to travel from the LA (80) throughthe stent-valve frame wall (750) and travel downstream (98) through theopen replacement leaflets (270) and out of the stent-valve into the LV(165) located downstream (98) of the stent-valve downstream end (740).Fluid flow from the LA (80) is not required to flow in a retrogradedirection (805) to enter into the upstream end (730) of the stent-valveframe (192) as found in existing stent-valve devices that causestagnation and resultant thromboemboli. This embodiment is well suitedto the patient that does not have native leaflets (790) that couldpotentially prolapse toward the LA.

FIGS. 41A and 41B show dual member stent-valve systems (195) of thepresent invention having the stent-valve frame (192) or second component(190) of a two component system (195) for heart valve replacement of thepresent invention. In FIG. 41A the securement band (865) is locatedintermediate between the upstream end (730) and the downstream end (740)of the stent-valve frame (192); in FIG. 41B, the securement band (865)is located at the downstream end (740) of the stent-valve frame (192).The stent-valve frame (192) can have an upper bulb (70) attached alongthe perimeter of the stent-valve frame (192) at a location adjacent toor upstream (202) of the securement band (865). The upper bulb (70)extends outwards (800) toward the upstream end (730) at an angle (range90-45 degrees from the frame axial direction. The upper bulb (70) helpswith positioning of the stent-valve frame (192) such that the upper bulb(70) rests upon the left atrial surface of the mitral leaflet, forexample or the upper bulb (70) is positioned just upstream (202) of thenative mitral valve leaflet shoulder (962) adjacent to the LA wall(972). Also, the upper bulb (70) can have a covering (285) attached toits surface to assist with preventing perivalvular leaks that can formbetween the outside (880) of the stent-valve frame (192) and the nativetissues or first component (200) member that is located on the outside(880) of the stent-valve frame (192). The barb tip (255) is able topenetrate through the covering (285) and into the annulus (20) as thebarb tip (255) is activated. The upper bulb (70) is able to rest in aconfiguration adjacent to the stent-valve frame (192) as the stent-valveframe (192) is being delivered within the delivery sheath (105). Theupper bulb (70) is constructed of Nitinol such that release of thestent-valve frame (192) from the delivery sheath (105) allows the upperbulb (70) to spring outwards (800) into the configuration shown in FIG.41A. The upper bulb (70) can be withdrawn along with the stent-valveframe (192) into the delivery sheath (105) to allow the stent-valveframe (192) to be repositioned or removed if necessary.

The stent-valve frame (192) can have a lower bulb (970) attached alongthe perimeter of the stent-valve frame (192) at a location adjacent toor downstream (98) of the securement band (865). The lower bulb (970)extends outwards (800) toward the downstream end (740) at an angle(range 90-45 degrees from the frame axial direction. The lower bulbhelps to lock and prevent migration of the stent-valve frame (192) viageometric shape around the first component distal end (965) when thestent-valve frame (192) is being placed subsequent to placement of afirst component (200). The lower bulb alternately can lock onto thenative mitral valve leaflets (790) or lock downstream (98) of the nativemitral valve shoulder (962) or native leaflet rim to prevent migrationof the stent-valve toward the left atrium (80) Also, the lower bulb canhave a covering (285) attached to its surface to assist with preventingperivalvular leaks that can form between the outside (880) of thestent-valve frame (192) and the native tissues, native leaflets (790),or first component (200) member that is located on the outside (880) ofthe stent-valve frame (192). The lower bulb is also constructed ofNitinol such that it has a smaller diameter configuration duringdelivery within the delivery sheath (105); the lower bulb can bewithdrawn back into the delivery sheath (105) following its release fromthe delivery sheath (105).

FIG. 42A shows the mitral valve annulus (20) with the left atrial wall(972) (of the left atrium (80) (LA)) extending upstream (202) of themitral annulus (20) and the left ventricular wall (975) (of the leftventricle (165) (LV)) extending downstream (98) of the annulus (20). Thenative mitral leaflet is attached to the mitral valve annulus (20) atthe native mitral leaflet base (976) at the junction of the left atrium(80) with the left ventricle (165). A mitral leaflet rim (977) extendsaround the perimeter of the mitral valve annulus (20) forming acontinuous perimeter of leaflet tissue. The mitral leaflet rim (977)forms a mitral leaflet shoulder (962) that forms a perimeter of theleaflet rim at a location where the leaflet tissue is divided to form anative anterior mitral leaflet (150) and a native posterior mitralleaflet (170). Two mitral valve leaflets (790) extend downstream (98)from the mitral valve rim; each mitral valve leaflet is attached attheir free edges (295) via cordae tendineae (177) to papillary muscles(178) that are contiguous with the left ventricular wall. The cordaetendineae (177) prevent the mitral leaflets (790) from prolapsing intothe LA (80) during systolic contraction of the LV (165) which can resultin mitral regurgitation with consequential negative sequellae.

An embodiment of the first component (200) of the present invention isshown in FIGS. 42A and 42B to demonstrate one potential position of thefirst component (200) relative to the surrounding mitral valve tissues.The structure of the first component (200) can also be found in otherembodiment drawings for the first component (200). The first componentframe (982) is allowed to expand elastically outward such that it isplaced into contact with a portion of the native mitral leaflet near thenative leaflet base (976); the first component frame (982) extendsinwardly (928) from the native leaflet base (976) along the nativeleaflet rim (977); the upstream frame region (978) of the firstcomponent frame (982) extends upstream (202) and radially outwards (800)along a portion of the LA wall (972); this first component upstreamframe region (978) can form a flange-shaped portion that extendsoutwards (800) at an angle with respect to the central axis (45), or canextend upstream (202) in the direction of the central axis (45) (30-90degrees from the direction of the central axis (45)). A barb strut (260)is attached to the first component frame (982); the barb strut (260) hasa balloon-expandable (BE) barb hinge (979) that allows the barb strut(260) to undergo a plastic deformation if it is exposed to a deformationforce (such as from the torus balloon (35) of the present invention, forexample) that causes the barb strut (260) to be pivoted along the barbhinge (979). A barb tip (255) located at one end of the barb strut (260)is shown in an activated configuration having the barb tip (255)embedded into the mitral valve annulus (20) or surrounding tissues ofthe mitral valve. The barb tip (255) holds the first component (200)securely to the mitral valve surrounding tissues and prevents migrationof the first component frame (982) upstream (202) towards the LA (80)and also assist in stabilizing the first component (200) from migrationdownstream (98) towards the LV (165). The barb tips (255) are able topenetrate through the covering (285) to extend into the surroundingtissues during activation of the barb tips (255). Alternately, thecovering (285) can be located inwards (928) of the barb strut (260) orinwards (928) of the activating torus balloon (981) while being attachedto the upstream end and downstream end of the first component frame(982) such that the covering does not interfere with the barbs (25) orrequire penetration by the barbs (25) through the covering (285) duringactivation of the barbs (25). All or a portion of the first componentframe (982) can have a covering (285) attached to the frame surface tohelp ensure that perivalvular leakage or leakage of blood through thefirst component frame (982) does not occur; the covering (285) is formedfrom a thin fabric including Dacron and expanded polytetrafluoroethylene(ePTFE) and other fabrics which will prevent blood flow through thefabric. The barb tip (255) can be straight and extend for a distance of3 mm (range 1.5-6 mm) or the barb can have a barb tip (255) that formsan arc and has a curved barb tip (980); the curved barb tip (980) canarc in an upstream (202) direction such that the curved barb tip (980)forms a stable configuration within the LA wall (972) or other nativetissues to prevent migration of the first component (200) upstream(202), for example. Alternately, the curved barb (980) can arc in adownstream direction (98).

As shown in FIG. 42B, an activating torus balloon (981) is located alongthe perimeter of the first component frame (982) on the inward (928)side of the barb strut (260). A plurality of backing elements arelocated on an inward-facing (928) surface of the activating torusballoon (981) at locations radially inward (928) from each of the barbstruts (260) to provide backing support to the activating torus balloon(981) such that balloon inflation will cause the activating torusballoon (981) to push the barb strut (260) outwards (800). The backingelements (450) are attached to the first component frame (982) atattachment sites that will provide tension to the backing elementsduring inflation of the activating torus balloon (981) and allow thetorus balloon to transfer its inflation pressure outwards (800) toactivate the barbs (25). The activating torus balloon (981) can beinflated via an inflation port (983) to cause activation of the barbs(25) in an outward direction to place the barb tips (255) into thesurrounding mitral tissue. An inflation port (983) connected to theactivating torus balloon (981) extends into and throughout a deliverysheath (105) and further extends outside (880) of the patient such thatan operator can inflate the activating torus balloon (981) after thefirst component (200) has been placed via elastic expansion of the firstcomponent frame (982) into intimate contact with the mitral valveannulus (20).

Recapture members (100) (described also in previous embodiments) thatare attached to the first component (200) allow the first componentframe (982) to be released from a delivery sheath (105) and placed intocontact with the mitral annulus (20), but still can be repositionedwithin the mitral surrounding tissues or removed by withdrawing thefirst component frame (982) back into a delivery sheath (105). Therecapture members (100) can be permanently affixed or contiguous withthe first component frame (982). A plurality of control fibers (120) canbe temporarily attached or looped through a holding feature (110) suchas a ring that is attached to the upstream end (730) of the firstcomponent frame (982) or the upstream end (730) of the recapture struts(100); one end of the control fibers (120) can be released from thefirst component frame (982) once positioning of the first componentframe (982) has been deemed acceptable by the operator, and the controlfibers can be removed from the body.

A limiting cable (225) is located along the perimeter of the firstcomponent frame (982); the limiting cable (225) can be formed into thestrut structure of the first component frame (982) such that thinflexible limiting struts, for example, formed as a zig-zag structure(335) into the first component frame (982) reach a geometricalconfiguration (via opening the zig-zag structure (335) into a linearconfiguration that can no longer extend in circumferential length) thatextends around the perimeter of the first component frame (982) andforms a closed ring that is unable to extend to a larger perimeter andthereby limit the perimeter of the first component (200). The limitingcable (225) prevents the first component frame (982) from applying acontinued outward force onto the mitral annulus (20) due to the elasticcharacter of the SE Nitinol frame once the stent-valve frame (192) hasreached a specified limiting diameter controlled by the limiting cable(225). The limiting cable (225) also provides a fixed ring structureinto which a second component (190), such as a stent-valve can be placedand held via a friction fit to the first component (200) or via ageometrical shape that locks the second component (190) to the firstcomponent (200). The limiting cable (225) can have a smaller limitingcable diameter (985) than the mitral valve annulus diameter and smallerthan a fixation ring diameter (984), the fixation ring diameter (984)being the diameter of a fixation ring (986) of the first component frame(982) at a location where the barb tips (255) are entering the mitralvalve annulus (20). The smaller limiting cable diameter (985) (smallerthan the fixation ring diameter (984) for one embodiment) allows asmaller diameter for a second component (190) stent-valve to be lockedinto the first component (200) forming a system lock (8) at the locationof the limiting cable. Thus for patients with widely varying andenlarged annulus diameters (997), fewer sizes (i.e., fewerdiameter-based stent-valve frames (15)) for the second component (190)are needed to cover a large range of annulus diameters (997) found inpatients with annulus diameters (997) ranging from 25 to over 55 mm indiameter. The limiting cable (225) can be 10 mm smaller in diameter(range 2-30 mm smaller in diameter) than the mitral annulus diameter(997) or fixation ring diameter (984). Also, the profile for the secondcomponent (190) stent-valve will be reduced due to the smaller limitingcable diameter (985). The benefit of a reduced profile will allow thepresent device to be delivered by the greatly preferred transseptalatrial approach rather than via the more patient-risky apical access.

The first component frame (982) can be formed from a hinge and strutstructure (such as described in FIGS. 50A-50C, for example) that is ableto conform to the oval or saddle shape of the mitral annulus, therebyproviding improved contact of the first component frame (982) with themitral annulus. The improved contact will provide improved attachment ofthe barbs with the surrounding mitral tissues along the entire perimeterof the oval annulus; also, improved contact will reduce liklihood forperivalvular leaks located at the small radius of curvature portions ofthe oval annulus. The limiting cable (225) located near the firstcomponent distal end (965) provides a closed ring into which the secondcomponent frame (192) can be delivered and expanded to form a frictionfit or geometrical fit such that it locks with the limiting cable as thesecond component frame (192) expands outward to form a round shape. Theround shape of the second component frame (192) provides the secondcomponent frame with the benefit of not requiring orientation around thecircumferential direction and the round shape helps to provide improvedleaflet symmetry and durability. Thus the first component proximal end(968) forms an oval shape to conform to the oval annulus and the firstcomponent distal end (965) has a round shape to provide a closed ringthat matches the rounded shape of the second component frame (192). Acovering (285) attached to the surface of the first component frame(982) ensures that leakage of blood cannot occur across the wall of thefirst component frame (982).

Alternately, the limiting can have a limiting cable diameter (985) thatis equal to the diameter of the mitral valve annulus (20) or fixationring diameter (984) such that the second component (190) can enterwithin the perimeter of the limiting cable (225), the limiting cablediameter (985) being the diameter of a circle having the same perimeteras the limiting cable (225). The limiting cable (225) can be located atthe first component distal end (965) or located at the position of thefirst component fixation ring (986).

FIGS. 43A and 43B show the delivery method for the first component (200)to the mitral valve surrounding tissues. The first component (200) isdelivered to the site of the mitral annulus (20) via a delivery sheath(105); the first component (200) is expelled from the delivery sheath(105) using a pusher member (122) or other means used in the medicaldevice industry. The first component (200) expands outwards (800) via SEelastic stored energy of the Nitinol or other elastic metal frame andcomes into contact with the mitral annulus (20). The first component(200) is being held by control fibers (120) that extent into thedelivery sheath (105) as shown in FIG. 43A. The control fibers (120) aretemporarily attached or looped though a holding feature (110) such as aring located in the upstream end (730) of the recapture struts (100) orthe first component frame (982). Once the physician determines that theposition of the first component (200) is acceptable; the operator isable to reposition the first component (200) or remove the firstcomponent (200) back into the delivery sheath (105) using the controlfibers (120) that extend to the proximal end of the delivery sheath(105). After the position for the first component (200) has beenestablished (i.e., the fixation ring (986) is located adjacent to theleaflet base or mitral valve annulus (20)), the activating torus balloon(981) is inflated to push the barb tips (255) outwards (800) into thesurrounding mitral valve tissues as shown in FIG. 43B. The barb tips(255) are able to penetrate through the covering (285) and extend intothe surrounding tissues. The position of the first component (200) isstabilized during barb activation via the control fibers (120) andrecapture members (100). The control fibers (120) can be removed orrecapture members (100) can be released from the delivery sheath (105)to deliver the first component (200) to the mitral valve surroundingtissues as shown in FIG. 43B. A covering (285) is attached to all or aportion of the first component frame (982). The covering (285) assistsin making a good seal between the first component frame (982) and thesurrounding tissues to prevent perivalvular leaks, particularly afterthe surrounding tissues have had a chance to ingrow into the micro-poresof the covering (285) material. The penetration of fibrous tissues intothe pores of the covering (285) assists in stabilizing the firstcomponent (200) from axial migration towards the LV (165) or LA (80).

FIGS. 44A to 44C shown an embodiment for the first component (200) thatis repositionable and removable even after the activating torus balloon(981) has been inflated to activate the barbs (25) outward into thesurrounding tissues. The structural elements of this embodiment are thesame as described in the previous embodiment shown in FIG. 42A and inother embodiments except with the addition of a deactivating torusballoon (987). The deactivating torus balloon (987) is attached alongthe perimeter of the first component frame (982) along the inwardsurface of the first component frame (982). The struts or structuralstent elements of the first component frame (982) provide support to theoutward surface of the deactivating torus balloon (987). Thedeactivating torus balloon (987) can be attached along the insidessurface of the first component frame (982) around the perimeter of thefirst component frame (982). The deactivating torus balloon (987) has adeactivating torus balloon inflation port (988) that allows thedeactivating torus balloon (987) to be inflated independently from theactivating torus balloon (981).

As shown in FIG. 44A the first component frame (982) has been partiallyreleased from a delivery sheath (105) and has expanded outwards (800)(relative to the central axis (45)) via SE character of the firstcomponent frame (982) to a diameter that makes contact with the mitralannulus (20). The first component (200) is being held by control fibers(120) that are temporarily attached to recapture members (100), therecapture members (100) being attached or contiguous with the upstreamend (730) of the first component (200). The control fibers (120) extendinto a delivery sheath (105) such that the first component (200) can bewithdrawn back into the delivery sheath (105) by application of tensionto the recapture members (100) and control fibers (120). The activatingtorus balloon (981) which is located inwards (928) from the barb struts(260) is noninflated; the deactivating torus balloon (987) locatedoutwards (800) of the barb struts (260) is also noninflated. A covering(285) is attached to all or a portion of the first component frame (982)to provide an improved seal between the first component frame (982) andthe surrounding tissues; the improved seal assists with preventingperivalvular leak and helps to provide stabilization against framemigration as surrounding tissues integrate into the pores of thecovering (285). The barb tips (255) are able to penetrate through thecovering (285) during activation of the barb tips (255).

As shown in FIG. 44B, the activating torus balloon (981) has beeninflated to activate the barbs (25) outwards (800) placing the barbstrut (260) into contact with the uninflated deactivating torus balloon(987) and applying an outward force to the barb strut (260) to place thebarb tip (255) to the outside (880) of the first component frame (982)and into the mitral valve surrounding tissues. If the operator does notapprove of the positioning of the first component (200) relative to theannulus (20), for example, the activating torus balloon (981) can bedeflated via application of vacuum or via disconnecting the activatingtorus balloon inflation port (983) to allow the inflation fluid to leakout of the inflation port (983) of the activation torus balloon. Thedeactivating torus balloon (987) can then be inflated to push the barbstruts (260) inwards (928) as shown in FIG. 44C. The inward force (989)supplied by the deactivating torus balloon (987) is supported by thefirst component frame (982) which is in contact with the outward-facingsurface (on the outwards (800) side of the deactivating torus balloon(987)) of the deactivating torus balloon (987). The barb tips (255) willthen move inwards (928) to a location inwards (928) of the firstcomponent frame (982) and the barbs (25) will then be in an inactiveconfiguration. The first component frame (982) can then be repositionedor removed using the control fibers (120) placed under tension to pullthe first component (200) back into the delivery sheath (105).

Other methods of deactivating the barbs (25) are anticipated. Forexample, the barb strut (260) can easily be bonded to the activatingtorus balloon (981) using standard bonding methods. Following inflationof the activating torus balloon (981) and activation of the barbs (25),the activating torus balloon (981) could then be exposed to a vacuum topull the barb strut (260) inwards (928) and cause the barb tip (255) tobe removed from the surrounding mitral valve tissue, and the barb tobecome deactivated. This alternate embodiment would require that thebacking member (450) be formed from a rigid material such as a rigidmetal and the activating torus balloon (981) would be bonded to thebacking member (450) using standard bonding methods. The backing member(450) would provide the support that would allow a vacuum containedwithin the activating torus balloon (981) to pull the barb strut (260)inwards (928) such that the barb is no longer activated. The activatingtorus balloon (981) in this alternate embodiment would serve as both anactivating torus balloon (981) and a deactivating torus balloon (987).

FIG. 45 shows an embodiment for the second component (190) orstent-valve component (190) of the two component system (195) of thepresent invention. The stent-valve frame (192) of this embodiment has agenerally cylindrical stent frame body (992) with a supra-securementlocking feature (990) located upstream (202) of the securement band(865) and an infra-securement locking feature (991) located downstream(98) of the securement band (865). The stent-valve frame (192) has asecurement band (865) that has a covering (285) attached along aperimeter of the stent-valve frame (192); the securement band (865) isintended to be located axially along the stent-valve frame (192) suchthat it is in contact with and radially inward (928) from the limitingcable (225) of the first component (200) or other locking feature orgeometric locking shape formed into the first component frame (982) thatforms a system lock (842). A tight friction fit between the securementband (865) and the limiting cable (225) ensures that blood is unable toleak between these two components. A supra securement locking feature isattached to the stent-valve frame (192); the supra-securement lockingfeature (990) extends outwards (800) from the stent-valve frame body(992) and makes contact with the upstream frame region (978) of thefirst component frame (982); the feature extends outwards (800) from thestent-valve frame body (992) by approximately 3 mm (range 1-6 mm). Thesupra-securement locking feature (990) can have, but is not required tohave, a covering (285) attached to all or a portion of its surface. Anopen supra-securement locking feature (990) can allow for blood flowthrough the stent-valve frame wall (750) without creating bloodstagnation regions (760). The infra-securement locking feature (991) isintended to be placed downstream (98) of the limiting cable (225) of thefirst component (200) or other locking feature or geometric lockingshape found in the first component frame (982). The infra-securementlocking feature (991) will prevent movement of the second component(190) or stent-valve component (190) in a retrograde direction (805)toward the LA. The infra-securement locking feature (991) can extendaround the entire perimeter of the first component (200). Alternately,the infra-securement locking feature (991) can extend along only aportion of the perimeter of the second component (190); a portion of thefirst component frame (192) perimeter that faces the native anteriorleaflet may not be preferable to contain the infra-securement bandlocking feature to avoid pushing the native anterior leaflet toward theLVOT.

The second component (190) of this embodiment is intended to straddlethe mitral annulus (20) and thereby contains an upstream-planar frameportion (930) or supra-securement band portion (930) that extends intothe LA (80) and a downstream-planar frame portion (932) orinfra-securement band portion (932) that extends into the LV. Thedownstream-planar frame portion (932) that extends into the LV (165) hasa downstream-planar frame length (938) of 10 mm (range 5-15 mm) suchthat the stent-valve frame (192) does not extend into the LVOT and doesnot push the anterior native mitral leaflet into the LVOT. Thestent-valve frame (192) does extend far enough into the LV (165) toensure that the native mitral leaflets (790) cannot overhang thedownstream end (740) of the stent-valve frame (192). The stent-valveframe (192) is open (without a covering (285)) in the opendownstream-planar intra-leaflet frame surface (890); the open surface(885) allows blood to flow between the stent-valve frame (192) and theluminal surface of the native leaflets thereby preventing bloodstagnation and potential thrombosis in this region. The stent-valveframe surface is covered in the closed downstream-planar inter-leafletframe surface (872) to prevent blood from an retrograde flow pathwithout proper valve control from the downstream end (740) to theupstream end (730) of the stent-valve frame (192). The upstream-planarframe portion (930) has an open surface (885) (i.e., no covering (285))in the open upstream-planar inter-leaflet frame surface (922); thisallows direct blood flow from the LA (80) into the lumen of thestent-valve frame (192) without requiring entry into the upstream end(730) of the stent-valve frame (192); this prevents regions of bloodstagnation in the LA. The upstream-planar frame portion (930) has aclosed upstream-planar intra-leaflet frame surface (920). Thesupra-securement band and infra-securement band locking feature can havea covering (285) attached to all or a portion of each of the lockingfeatures to provide an improved seal with the surrounding tissues and toassist with prevention of perivalvular leak.

FIGS. 46A and 46B show the delivery of the second component (190) of adual member stent-valve (195) having the second component (190) placedinto the central lumen (265) of the first component (200) and lockingthe second component (190) to the first component (200) to form a systemlock (842). As shown in FIG. 46A, the first component (200) has beendelivered to the mitral annulus (20) and has been attached to the mitralannulus (20) via activation of the barb tips (255) into the surroundingmitral tissues. The first component stent frame (982) extends downstream(98) from the location that the barb tips (255) extend through the stentframe; the first component (200) extends further inwards (928) to adiameter that is less than the mitral annulus diameter (997). Thelimiting cable diameter (985) can be 10 mm less (range 2-30 mm less)than the diameter of the mitral annulus (20). The limiting cable (225)that extends around the perimeter of the first component (200) can belocated, for example, at the distal end (965) of the first component(200) as shown in FIG. 46A such that the limiting cable diameter (985)is less than the mitral annulus diameter (997) and can serve, forexample, as a closed securement ring (755) onto which the secondcomponent (190) can be locked via geometrical shape fit or via frictionfit. The mitral annulus diameter (997), stent frame diameter, limitingcable diameter (985), securement band diameter (999), and other devicecomponent diameters that are used in the present specification representthe diameter of a circle that has a perimeter of the mitral annulus(20), perimeter of the stent frame, or perimeter of the limiting cable(225), respectively, for example. It is noted that the limiting cablediameter (985) can be as large as the diameter of the mitral annulus(20) such that the second component (190) is able to be delivered withinthe closed ring formed by the limiting cable (225).

The barb tips (255) have been activated and extend through the firstcomponent frame (982) into the surrounding mitral valve tissue at alocation near the base of the mitral valve leaflets (790). The barb tip(255) extends approximately 3 mm (range 1.5-6 mm) into the surroundingtissues such that barb tip (255) does not allow for migration of thefirst component (200) and does not extend too far into the tissue tointerfere with the circumflex artery or extend into the aortic arteryluminal space. The first component (200) can be placed without requiringorientation around the angular direction with respect to the centralaxis (45) of the mitral annulus (20). The first component stent frame(982) extends from a first component distal end (965) having a locationnearest to the LV (165) to a location upstream (202) toward the LA (80)and outwards (800) at an angle of 20 degrees (range of 90 to zerodegrees; shown best in FIGS. 44A-44C) with respect to the central axis(45) of the first component (200) along the shoulder or rim of themitral leaflets (790); the first component frame (982) extends furtherupstream (202) and outwards (800) upstream (202) of the native leaflets(790) at an angle of 20 degrees (range zero to 80 degrees) with respectto the central axis (45) of the first component (200)) along a portionof the left atrial wall to the first component (200) proximal end (968)(see FIGS. 44A-44C).

The second component (190) is delivered via a delivery sheath (105) asshown in FIG. 46A. The second component (190) is partially released fromthe delivery sheath (105) and allowed to expand under elastic SE stentstored energy to a location such that the infra-securement lockingfeature (991) is released and can be positioned downstream (98) of thesecurements ring (such as the limiting cable (225)) of the firstcomponent (200). The infra-securement locking feature (991) extendsoutwards (800) to a infra-securement locking feature diameter (993) thatis larger than the limiting cable diameter (985) by 4 mm (range 2-10mm). The delivery sheath (105) can then be retracted proximally whileholding position of the stent-valve to release the supra-securementlocking feature (990) above the securement ring (755) (such as theannulus (20), for example) or limiting cable (225) of the firstcomponent (200). The supra-securement locking feature (990) has asupra-securement locking feature diameter (994) that is 4 mm (range 2-10mm) larger than the limiting cable diameter (985) or geometric lockingfeature of the first component frame (982). The stent-valve can bepushed downstream (98) via compression to the delivery sheath (105) ortension to the delivery sheath (105) to ensure that the stent-valve islocked onto both sides of the securement ring (755) of the firstcomponent (200) via the locking features of the second component (190)as shown in FIG. 46A.

The second component (190) is still attached to the delivery sheath(105) via control fibers (120) which are temporarily attached or loopedthrough holding features (110) located at the upstream end (730) ofrecapture struts (100) or upstream end (730) of the second component(190); the control fibers (120) extend into the delivery sheath (105)and allow the operator to pull the second component (190) back into thedelivery sheath (105) if the second component (190) or stent-valvecomponent (190) is not acceptably positioned across the mitral valveannulus (20). Upon verification that the second component (190) isfunctioning properly and the position is proper, the control fibers(120) can be removed and the recapture members (100) can be releasedfrom the delivery sheath (105) to fully release the second component(190) as shown in FIG. 46B. The infra-securement locking featurediameter (993) is larger than the limiting cable diameter (985) toensure that the second component (190) is locked into the firstcomponent (200) via geometrical constraints and is unable to migratetoward the LA. The infra-securement locking feature (991) can be locateddownstream (98) of the annulus (20) or downstream (98) of the nativeleaflet rim. The infra-securement locking feature (991) diameter can belarger than the annulus diameter (997) or native leaflet rim (977) andcan push outwards (800) against the native leaflet at a locationdownstream of the native leaflet rim (977) in the LV (165) to furtherprevent the second component (190) from migrating toward the LA (80) asshown in FIG. 46B. The infra-securement band locking feature can extendaround the entire perimeter of the first component (200) or alternately,along only a portion of the perimeter of the first component (200) toavoid pushing the native anterior leaflet into the LVOT.

The infra-securement locking feature diameter (993) can be 4 mm (range0-6 mm) larger than the annulus diameter (997). Since the firstcomponent (200) and second component (190) are locked together via thelocking features located upstream (202) and downstream (98) of thelimiting cable (225) to form a system lock (842), the first component(200) is also prevented from migrating toward the LA (80) due to theinfra-securement locking feature (991). The infra-securement lockingfeature (991) thereby reduces the axial force exerted by the LV pressurethat acts to push the mitral valve system towards the LA; the axialforce transmitted onto the barbs (25) of the first component (200) isthereby reduced, reducing the likelihood of dehiscence from the barbs(25) due to micro movement which can occur relative to the surroundingtissues during each cycle of the beating heart. The barbs (25) of thefirst component (200) can then be allowed to form an improved healingresponse with the surrounding tissues without the liklihood forinflammatory response due to relative movement between the barb tip(255) and the surrounding tissues. To further reduce the chances forinflammation at this site the barb tips (255) can be coated with abiocompatible material such as a microporous polyurethane, porousDacron, or other microporous, fibrous, or biocompatible material thatprovides for cellular attachment, cellular incorporation, or favorablecellular healing.

One feature of the present invention relates to limiting the number ofsizes needed for the first or second component (190) to meet the varyingdiameters for mitral valve annulus (20) found in patients. By providinga limiting cable (225) with a smaller limiting cable diameter that themitral annulus (20), the number of sizes for the second component (190)can be reduced since the second component (190) is sized to fitfrictionally or geometrically within the closed ring provided by thelimiting cable (225).

Another feature of the present invention is that the first componentframe (982) can be formed of a hinge and strut structure such as thatshow in FIGS. 50A-50C, for example. The hinge and strut structure of thefirst component can conform to an oval or saddle shaped annulus in theregion of the first component frame (982) that is adjacent to theannulus. The first component frame (982) can be very conformable to forma rounded shape at the location of the limiting cable near the firstcomponent distal end (965). Thus the compliant portion of the firstcomponent frame (982) adjacent to the annulus makes full apposition withthe oval annulus to allow the barbs to embed themselves into thesurrounding mitral tissue along the entire perimeter of the mitralannulus, and also, the full apposition will prevent the formation ofperivalvular leaks on the outside of the first component frame (982)between the first component frame (982) and the native mitral tissues.The first component frame (982) near the first component distal end(965) can have a rounded shape in its expanded configuration. Thelimiting cable is further forced into a round shape by the expansionforces of the second component frame (192) into the region of thelimiting cable; the limiting cable serves as a closed ring into whichthe second component frame (192) is locked via frictional forces or viageometrical shape features found in the first component frame (982) andsecond component frame (192).

The use of such a limiting cable diameter (985) that is smaller than theannulus diameter or first component diameter at a location adjacent tothe mitral annulus can create within the second component (190) agreater challenge to have an infra-securement locking feature diameter(993) larger than the mitral annulus (20) and still be withdrawn backinto the delivery sheath (105) for possible repositioning or removal. Anembodiment intended to address this concern is shown in FIG. 46C. Inthis embodiment a frame extension (995) is attached to the outside (880)of the stent frame of the second component (190) in the region of thestent frame upstream (202) and downstream (98) of the securement band(865) such that the supra-securement locking feature (990) andinfra-securement locking feature (991) are attached to the frameextension (995). The frame extension (995) has a frame extensiondiameter (996) that extends outwards (800) to fit snugly with frictionwithin the closed ring of the limiting cable (225) found in the firstcomponent (200) or securement ring. The limiting cable diameter (985)can be approximately equal to the mitral annulus diameter (997). Theframe extension diameter (996) is 6 mm (range 5-30 mm) larger indiameter than the stent-valve frame body diameter (998) that containsthe replacement leaflets (270). The supra-securement locking feature(990) and infra-securement locking feature (991) extend outwards (800)from the stent-valve frame (192) by 4 mm (range 2-10 mm) on each side ofthe stent-valve frame (192).

As shown in FIG. 46D, when the second component (190) is placed withinand locked within the first component (200) forming a system lock (842),the infra-securement locking feature (991) is able to push outwards(800) onto the native leaflet (790) downstream (98) of the mitralannulus (20) thereby providing additional assistance against upstream(202) migration. The stent-valve frame body (992) that houses theleaflets (270) can have a stent-valve body diameter that is 5-30 mmsmaller than the mitral annulus (20) thereby allowing a lesser number ofsizes for the stent-valve frame body (992) and leaflet subcomponent; thestent-valve frame body (992) can be combined via a permanent attachmentor an attachment that can be locked in place via a secondary step with aframe extension (995) to form the stent-valve frame (192) and meet thevaried patient's mitral valve annulus diameters (997). The stent-valveframe (192) can have a stent-valve frame diameter that is 10 mm smaller(range 2-30 mm smaller) than the mitral annulus diameter (997) therebyreducing the profile for the stent-valve frame (192).

Several designs are contemplated for the stent valve extension. Theextension can take the form, for example of an outer stent that placeover and attached to the stent-valve frame (192). Alternately, the frameextension (995) can be comprised of metal arms or paddles that extendoutwards (800) from the second component stent frame (192) to a diameterthat is larger than the stent-valve frame (192).

Other means of locking the second component (190) to the first component(200) are anticipated. The second component stent frame can be formed.for example, with a concave securement band (865) having a secondcomponent concave region (206) as shown in FIG. 47A. The secondcomponent concave region (206) has a covering (285) attached to it andforms a reduced diameter region having a securement band diameter (999)3 mm (range 1-5 mm) smaller than the stent-valve frame body diameter(998). The second component (190) is delivered via a delivery catheteras shown in FIG. 47B and released in a manner that places the securementband (865) axially adjacent to the securement ring (755) or limitingcable (225) of the first component (200). The second component (190) isheld via control fibers (120) which are temporarily attached or loopedthrough holding features attached to recapture struts (100) which areeither attached to the upstream end (730) of the first component (200)or are themselves frame elements of the first component (200). Thecontrol fibers (120) can be placed under tension by the operator at theproximal end of the delivery sheath (105) to provide for repositioningand removal of the second component (190) if required by the operator.Upon achieving a locking of the securement band (865) of the secondcomponent (190) adjacent to the securement ring (755) or limiting cable(225) of the first component (200) forming a system lock (842), thesecond component (190) is fully released as shown in FIG. 47C to formthe dual member stent-valve (195).

A dual-member stent-valve (195) is shown in FIG. 47D having ageometrical lock (1150) to lock the first component (200) to the secondcomponent (190). The first component (200) is attached to the mitralannulus (20) via barbs (25) that have been activated via a torus balloon(35). The first component is delivered to place the first componentdistal end (965) into contact with the native leaflet rim (977) andallowed to expand and conform to the oval or D-shaped annulus prior toactivation of the barbs. The first component frame (982) is formed witha frame structure that allows it to conform into small radius ofcurvature bends found in the D-shaped mitral annulus. The firstcomponent frame (982) can be formed with hinge and strut dimensions thatprovide for increased outward expansion force and increased bendingcharacteristics than standard stent structures as described later in thespecification. The inflation of the torus balloon (35) provides supportto the first component frame (982) to ensure that expansion forcessupplied by the torus balloon are transferred outwards to drive thebarbs (25) into the surrounding tissues and the first component framecannot move inwards (928) toward the axis (45) of the first componentframe (982). The first component frame (982) has a first component angle(1155) that is 35 degrees (range 20-75 degrees) off of the axis (45) andhas a smaller first component frame diameter at the first componentdistal end (965) than the first component frame diameter at the firstcomponent proximal end (968). A limiting cable (225) extends around theperimeter of the first component frame (982) and can be located near thefirst component distal end (965) as shown in FIG. 47D.

The second component (190) can have a second component concave region(206) located intermediate between the second component upstream end(730) and the second component downstream end (740) as shown in FIG.47D. The second component concave region (206) can have a rounded shape,can form a V-shaped divot, or any other geometrical shape that is ableto form a geometrical lock with the first component. As shown in FIG.47D, the second component concave region (206) has a second componentangle (1160) of 35 degrees (range 20-75 degrees) off of the axis (45)such that it matches the first component angle (1155) and forming atight fit or geometrical lock (1150) between the second component (190)and the first component (200). The second component (190) is allowed toexpand into the lumen of the first component (200) such that the secondcomponent concave region (206) locks both upstream and downstream (98)of the limiting cable (225) found on the first component forming ageometrical lock (1150) that prevents migration of the second component(190) with respect to the first component (200). The first componentangle (1155) and the second component angle (1160) form a cone-in-conealignment of the second component (190) with the first component (200)along the axis (45), and also position the second component (190)axially such that the second component concave region (206) ispositioned to lock both upstream and downstream (98) of the limitingcable (225).

Other embodiments are anticipated having the second component concavelocking region (206) or geometrical lock (1150) located at variouslocations along the second component frame (192) as described earlier inthis specification. The geometrical lock (1150) can be formed via convexregions of the first component (200) and second component (190) or othergeometrical or mechanical locking mechanisms used to hold a cylindricalor frustum-shaped first frame from migrated in an axial direction withrespect to a cylindrical or frustum-shaped second frame that is locatedwithin the central lumen (265) of the first frame. It is anticipatedthat the first component axial length (1165) is 13 mm (range 8-25 mm).The second component axial length (1170) can be 21 mm (range 15-35 mm),for example, and can have 16 mm, for example, (range 15%-100% of thesecond component axial length (1170)) extending into the LA (80). It isanticipated that 6 mm (range 3-15 mm) of the second component axiallength (1170) extends into the LV (165) to prevent the native leaflets(790) from interfering with the function of the replacement leaflets(270).

FIG. 47E shows a structure for the second component frame (192) for thesecond component (190) of the present invention. The second componentframe (192) can have a zig-zag structure with an upstream end (740) anda downstream end (730). The replacement leaflets are attached to thesecond component frame (192) along a generally crown-shaped leafletattachment (275) found in the second component frame (192). Attached tothe upstream end (730) are recapture struts (100) that are morecompliant than the second component frame body (992) and provide atransitional amount of flexibility to allow the second component frame(192) to be withdrawn into the delivery sheath. The recapture struts(100) are more flexible to allow ease of entry into the delivery sheathduring withdrawal of the second component (190) into the delivery sheathif it is necessary to reposition or remove the second component from itsdelivered location within the central lumen of the first component. Therecapture struts (100) have holding features (110) such as eyelets, forexample, that allow control fibers to be looped through the eyelets;control for holding and releasing of the recapture struts can beperformed by the operator by releasing one end of the control fiber, forexample, to allow the second component to be released completely fromthe delivery sheath.

One embodiment for the first component (200) includes two barb rings tohold the stent frame against the surrounding tissues and preventmigration of the first component (200) upstream (202) towards the LA(80) as shown in FIG. 48. The stent frame has an upstream barb ring(1000) that contain a plurality (range 8-32) of upstream barb struts(1005) located along the perimeter of the first component frame (982)and are attached to the first component proximal end (968) of the stentframe via upstream hinges (1010). The upstream barb struts (1005) attachto upstream barb tips (1015) that can be activated such that theypenetrate into the surrounding tissues at or near the mitral valveannulus (20). An upstream activating torus balloon (1020) extends aroundand is attached to the perimeter of the stent frame and makes contactwith the upstream barb struts (1005) such that inflation of the upstreamtorus balloon causes the upstream barbs (25) to become activated asshown in FIG. 48. The stent frame also has a downstream barb ring (1025)that contain a plurality (range 8-32) of downstream barb struts (1030)that are attached along a perimeter of the first component distal end(965) of the stent frame via downstream hinges (1035). The downstreambarb struts (1030) attach to downstream barb tips (1040) that can beactivated such that they penetrate into the surrounding tissues at ornear the mitral valve annulus (20) or into the rim of the mitral valveleaflets (790). A downstream activating torus balloon (1045) extendsaround the perimeter of the stent frame and makes contact with thedownstream barb struts (1030) such that inflation of the downstreamtorus balloon causes the upstream barbs (25) to become activated asshown in FIG. 48. The upstream barb ring (1000) and downstream barb ring(1025) can be attached to the first component frame (982) such that theupstream barb tips (1015) and downstream barb tips are curved barb tipsand the curved barb tips can penetrate the surrounding valve tissues toform a clam-shell configuration such that the arcs of the barb tips aredirected toward each other to grab the valve tissues securely when thebarbs are activated.

The upstream torus balloon can have a separate upstream inflation port(1050) and the downstream torus balloon can have a downstream torusballoon inflation port (1055) such that the upstream torus balloon andthe downstream torus balloon can each be inflated independently viaseparate and independent balloon ports located at the catheter manifoldoutside of the patient's body and interfacing with the deliverycatheter. Alternately a single inflation port (983) can be used toinflate both the upstream activating torus balloon (1020) and downstreamactivating torus balloon (1045) at the same time if desired. Theupstream inflation port (1050) and downstream inflation port (1055) areremovably attached to the torus balloons via a threaded connection (525)or other junction connection (488) as described in earlier embodimentsof the present invention. A single backing element can extend from thestent proximal end (968) to the stent distal end (965) along the inwardside (928) (toward the central axis (45)) of the two torus balloons toprovide support to the torus balloons such that inflation of the torusballoons exerts an outward force against the barb struts to activate thebarb tips (255) to a region outside (880) of the stent frame and intothe surrounding tissues. The presence of two barb rings provides andadditional number of barbs (25) such that 32 barbs (25) (range 16-64barbs) are located along the perimeter of the stent frame to ensure thatmigration toward the LA (80) does not occur.

The present invention includes a plurality of barbs that are attachedalong the perimeter of the first component frame (982), and the barbsare activated via inflation of one or more torus balloons to push thebarb tips (255) into the mitral annulus (20). It is understood thatpatients can have mitral annular calcium (MAC) deposits along theperimeter of the mitral annulus. Penetration of the barb tips into theMAC tissue may be inconsistent thereby reducing the number of barb tipsthat are acting to hold the first component frame against the mitralannulus to prevent migration of the first component frame (982) towardthe LA (80) or toward the LV (165). To improve the penetration of thebarb tips (255) into the annular tissue in the presence of MAC the torusballoon is exposed to a pulsating pressure that transfers its force tothe barbs such that the barbs can penetrate the hard calcified tissues.The torus balloon can initially be inflated to a pressure of 5 atm(range 1-20 atm) to cause the barb tips to extend to the outside (880)of the first component frame (982). The inflation pressure to the torusballoon is then pulsed at a location of the catheter manifold locatedoutside of the patient's body. The pulsed pressure is transmitted via aninflation tube to the inflation port (983) located near the torusballoon. The inflation pressure is pulsed at a frequency of 10 Hertz(range 1-30 Hz) by using a positive displacement pump such as a pistonpump that is placed in fluid communication with the syringe or otherinflation device that the operator is using to inflate the torusballoon. The inflation pressure can be pulsed such that a pressuredifferential at the torus balloon is varied by 5 atm (range 1-20 atm) at10 Hz, for example. The torus balloon internal pressure can vary, forexample during each pulsed cycle from zero to 5 atm to cause the barbtips to cycle their way through the calcified plaque.

In addition to providing a device system for treatment of functionalmitral regurgitation, as well as forms of primary mitral regurgitation,the first component frame (982) of the first component (200) of thepresent invention can be used (without the need of the secondstent-valve component of the present stent-valve invention, for example)to treat degenerative mitral regurgitation which often presents with aflailed native leaflet (1060) as shown in FIG. 49A. The native leafletcan extend toward the LA (80) side of the mitral annulus (20) providingthe native leaflets (790) with a lack of full coaptation and resultingin a flow path for blood from the LV (165) back to the LA (80) duringsystole. One embodiment for the first component (200) of the presentinvention is shown in FIG. 49B. In this embodiment the first componentframe (982) has been delivered on the LA (80) side of the nativeleaflets (790) and mitral annulus (20) as described in previousembodiments. The barb tips (255) have been activated via an inflatedtorus balloon that extends around and is attached to the perimeter ofthe stent frame as described in previous embodiments. The barb tips(255) extend into the mitral annulus tissue (20), the native leafletbase (976), the native leaflet rim (977), or other surrounding tissuesof the mitral valve. The first component frame (982) extends to a firstcomponent distal end (965) with a frame distal end diameter (1065). Theframe distal end diameter (1065) is 10 mm smaller (range 5-30 mmsmaller) than the mitral annulus diameter (997). The downstream frameregion (1070) that extends downstream (98) from the location of the barbtips (255) provides support to the native leaflets (790) to prevent thenative leaflets (790) from everting towards or into the LA (80) as shownin FIG. 49B. The downstream frame region (1070) can be rounded or curvednear the first component distal end (965) to prevent contact abrasion ofthe native leaflet with the stent frame as the native leaflets (790)make contact with the downstream frame region (1070) during eachcontraction of the LV.

As described previously in this specification, the mitral annulus (20)has a saddle shape that when viewed from the top or from the LA (80)side looks like an oval shape. Often standard stented valves includingtranscather aortic valve replacement (TAVR) devices, and other deviceswith stent frames have difficulty making contact around the perimeter ofan oval-shape annulus (20) and leakage can occur around the stentedframe in regions where the oval has its smallest radius of curvature.Often stent-valve frames are formed by cutting a stent pattern orstructure out of a Nitinol tube; also stent frames can be formed fromzig-zag structure (335) from one or more Nitinol wires. Such stentmanufacturing methods often result in stent frames that are of acontinuous dimension in the radial dimension of the stent frame wall.These standard stent frame structures have limitations in theireffectiveness to function effectively to form a close apposition alongthe entire perimeter of an oval annulus. If the standard stent structureis formed from a smaller caliber of Nitinol wire or has a smaller radialdimension in order to conform to the oval shape, then the stentstructure may not apply enough of an outward expansion force against theannulus (20) to provide good apposition of the stent frame with thesurrounding tissues and prevent stent frame migration or perivalvularleak. If the standard stent structure is constructed with a largercaliber of Nitinol wire or with a larger radial dimension, then thestent structure will not bend into the small radius curves of the ovalshape and will not conform uniformly along the perimeter of the annulus(20).

Embodiments of the present invention for either the first componentframe (982) or second component frame (192) may be comprised of hinges(1072) and struts (1074) (as shown in FIGS. 50A-50C); the framestructure (1075) of the first component (200) and frame structure (1075)of the second component (190) has a hinge radial dimension (1080)extending in the radial direction (1082) that is greater than a strutradial dimension (1085) and a hinge width (1090) that is smaller than astrut width (1095); this is fully described in US patent entitled,Intravascular Hinge Stent, with U.S. Pat. No. 8,585,751 which is madereference to and is herein incorporated fully within the present patentapplication.

In one embodiment the frame structure (1075) of the first component(200) or second component (190) is formed from Nitinol (or other elasticmetal or polymer) that has been machined via laser and mechanicalmachining as shown in FIGS. 50A-50C. As shown in FIG. 50A the hingelength (1100) is greater than the hinge width (1090); the hinge length(1100) provides the frame structure (1075) with a self-expandingcharacter without undergoing plastic deformation; the hinge length(1100) can be 0.015 inches (range 0.010 to 0.060 inches). The hingewidth (1090) allows full hinge (1072) expansion deformation withoutexposing the hinge (1072) to plastic deformation; the hinge width (1090)is 0.004 inches (range 0.003-0.006 inches). The hinge radial dimension(1080) is greater than the strut radial dimension (1085); the hingeradial dimension (1080) provides the expansion force that pushes theframe structure (1075) outwards (800) against the annulus (20) duringexpansion deformation. The hinge radial dimension (1080) can be largerthan the radial dimension of a standard frame structure to provide evengreater outward expansion force than can be obtained with a standardframe structure having the same ability to conform with appositionagainst the perimeter of an annulus (20). The hinge radial dimension canbe 0.005 inches (range 0.004-0.010 inches).

As shown in FIG. 50B the frame structure (1075) is in an unexpandedconfiguration and the hinges (1072) are able to expand outwards in acircumferential direction (1105) elastically within the mitral annulusto cause the mitral annulus to place the frame structure (1075) intocontact with the mitral annulus and to reduce some of the oval shape ofthe mitral annulus. The hinge radial dimension (1080) prevents bendingof the hinge (1072) in the radial direction, but the strut (1074) isable to provide all of the bending necessary to make full contact of theframe structure (1075) with the small radius of curvature portion of anoval annulus (20).

The strut radial dimension (1085) is smaller than the hinge radialdimension (1080) such that the strut (1074) is able to bend easilyaround the small radius curve of an oval annulus (20). The strut radialdimension (1085) can be smaller than the radial dimension of a standardstent frame structure such that the strut (1074) can bend easier than astandard frame structure and provide full contact along the perimeter ofthe annulus (20), even in the smaller radius of curvature portion of anoval annulus (20). The strut radial dimension (1085) can be 0.003 inches(range 0.002-0.005 for a conforming elastic strut). The strut width(1095) is greater than the hinge width (1090) such that the strut (1074)does not bend in the circumferential direction (1105) as the hinge(1072) expansion forces cause the hinge (1072) to open and cause struts(1074) to align along a circumferential direction (1105) with the stentframe in an expanded configuration as shown in FIG. 50C. The strut width(1095) can be 0.005 inches (range 0.004-0.010 inches).

The result for this embodiment for the frame structure (1075) for thefirst component (200) is that the first component (200) (as described inother embodiments) will make full contact along the perimeter of firstcomponent frame (982) with the annulus (20) prior to activation of thebarbs (25). The first component frame (982) that is formed with thehinge and strut frame structure (1075) will not require circumferentialorientation during its placement within the oval annulus; the framestructure (1075) will conform to the oval annulus independent of itscircumferential orientation. The large outward expansion force appliedby the hinges (1072) allows the barbs (25) to push outwards (800) andembed themselves into the surrounding tissues along the entire perimeterof the first component frame (982); the frame structure (1075) supplyingthe force necessary for the torus balloon to push against to cause thebarbs (25) to become activated. In addition, the apposition of the firstcomponent frame (982) with the oval shape of the annulus will help toreduce locations for perivalvular leak in regions where the oval makessmaller radius of curvature bends at the long axis ends of the oval. Thestructure for the first component frame can include a generally roundedor circular configuration in the region of the first component frame(982) near the first component distal end (965). Delivery of the secondcomponent into the rounded or circular first component distal end (965)provides a locking of the first component frame (892) to the secondcomponent frame (192) to form the system lock (842) while maintainingthe second component frame (192) in a rounded configuration (i.e.,circular cross sectional shape) to help maintain optimal replacementleaflet coaptation and provide for replacement leaflet durability.

Another embodiment for the frame structure (1075) for the firstcomponent frame (982) or second component frame (192) as just describedfor FIGS. 50A-50C can be altered such that the strut radial dimension(1085) is not so thin that it bends easily around a small radius ofcurvature bend found in an oval annulus (20) but instead forms the ovalannulus (20) into a round annulus (20) (i.e., a round cross-sectionalshape when viewed from above the annulus; the strut radial dimension(1085) is more similar to the radial dimension of a standard stentstructure. The other aspects of the hinge (1072) and strut (1074)construction are the same as previously described. In this embodiment,the larger hinge radial dimension (1080) (i.e., larger than a standardstent frame radial thickness) frame structure (1075) is able to expandthe oval annulus (20) outwards (800) into a round cross-sectional shapeprior to activation of the barbs (25) found in the first component frame(982). Also, this embodiment of the frame structure (1075) can be usedin the second component frame to provide a round expanded configuration.The round configuration of the second component (190) will provide thereplacement leaflets (270) with a uniform shape that will provideoptimal leaflet coaptation (710) and allow for improved leafletdurability.

The dual member stent valve (195) of the present invention as well asembodiments of the single component stent-valve configurations are ableto conform to an oval or saddle shaped mitral annulus for attachment tothe mitral tissues and still provide a round securement band orcylindrical shape to the stent-valve component (190) orleaflet-containing portion of the stent-valve frame. In one embodimentas shown in FIG. 51A the first component frame (982) has an upstreamregion (978) that conforms well to the oval mitral annulus (20) and hasan oval first component cross-section (1110). The structure of the firstcomponent frame (982) can be the hinge and strut structure described inFIGS. 50A-50C or can be any other stent frame structure used in formingvascular stents or stent-valves. The limiting cable (225) of the firstcomponent (200) that is located near the first component distal end(965) forms a closed ring that can serve as a landing zone for locatingthe securement band (865) of the second component (190). The firstcomponent downstream frame region (1070) and the limiting cable (225)can be formed with a round cross-sectional shape or can form a roundcross-sectional shape upon delivery of a second component frame (192)into the first component frame (982). The limiting cable (225) can havea limiting cable diameter (985) that is smaller than the first componentframe diameter at a location where the barb (25) penetrates into thesurrounding native tissues. A round second component cross-section(1115) is formed into the second component frame (192). The round secondcomponent cross-section (1115) provides improved replacement leafletfunction without centro-valvular leakage and provides for improvedleaflet durability. The second component diameter (1140) of the roundsecond component cross-section (1115) can have a smaller secondcomponent diameter (1140) than the effective diameter (i.e., diameter ofa circle with the same perimeter) associated with a perimeter of theoval annulus or perimeter of the first component frame (192) at alocation adjacent to the annulus (20). The second component diameter(1140) can be equal to the limiting cable diameter (985). Thus theprofile of the second component frame (982) can be smaller than if itmatched the effective diameter of the annulus. Also, the same secondcomponent diameter (1140) can be used to fit within and lock by forminga system lock (842) into a variety of first component sizes which areintended to conform to a variety of annulus oval shapes and oval annulusperimeters. Thus the number of sizes for the second component to serve avariety of annulus diameters and annulus perimeters will be reduced.

Alternately, the stent-valve devices of the present invention can beconfigured such that the first component frame (982) has enough outwardexpansion force to cause the mitral annulus (20) to become rounded ornearly round with a round first component cross-section (1120) as shownin FIG. 51B. Placement of the second component frame (192) into thelumen of the first component frame (982) provides a round secondcomponent cross-section (1115). The second component frame (192) can beplaced such that it locks via friction or geometrical fit with the firstcomponent frame (982) at or near the limiting cable (225) to form asystem lock (842). The limiting cable can have a limiting cable diameter(985) that confers or provides a smaller second component diameter(1140) than the effective diameter of the first component frame (982) ata location adjacent to the annulus (20).

Further alternately, as shown in FIG. 51C the first component frame(982) can conform well to the oval annulus thereby forming an oval firstcomponent cross-section (1110) prior to delivery of the second component(190). After the second component (190) has been delivered into thelumen of the first component (200) as shown in FIG. 51D, the secondcomponent frame (192) has enough outward expansion force to form thefirst component frame (982) into a round first component cross-section(1120), and also provide a round second component cross-section (1115).The second component diameter (1140) can be approximately equal to (orless than) the first component frame diameter (1145) at a locationadjacent to the annulus (20).

In yet another embodiment the first component frame (982) conforms tothe oval annulus forming an oval first component cross-section (1110).Upon delivery of the second component (190) into the lumen of the firstcomponent frame (982), the second component frame (192) expands out tomeet the minor axis (1125) of the oval first component cross-section(1110). The second component frame forms a round second componentcross-section (1120) but with a second component reduced diameter (1130)that is equal to the minor axis distance (1125) of the oval firstcomponent cross-section (1110). A flange (1135) attached to the secondcomponent frame (192) ensures that blood cannot leak between the firstcomponent frame (982) and the second component frame (192). The flange(1135) can be comprised of the infra securement band locking frame(991), supra securement band locking frame, the upper bulb (70),covering, or other portion of the second component frame (192) or otherfeature capable of blocking blood flow or blood leakage between thefirst component (200) and the second component (190). The smaller secondcomponent reduced diameter (1130) (i.e., smaller than the effectivediameter of the first component frame (982) at a location adjacent tothe annulus (20)) provides this embodiment with a lower profile for thesecond component and a reduced number of sizes for the second component(190) that are required to meet the needs of the varied patient annulussizes, annulus diameters, and annulus perimeters.

Similar reference names and reference numbers used throughout thisspecification can be applied to all other embodiments found in thespecification. Various structural elements described throughout thisspecification can be applied to other embodiments within thespecification and are thereby understood to be included in the presentinvention.

1. The method for providing a passage for blood flow through a surfaceof an expandable stent-valve frame that is implanted via transcatheterimplantation into native mitral valvular tissues of a heart, saidstent-valve frame having two or more replacement leaflets attached tosaid stent-valve frame, said stent-valve frame having a coveringattached to at least a portion of said stent-valve frame, said methodcomprising, A. providing said stent-valve frame wherein said replacementleaflets are attached to said stent-valve frame along a crown-shapedattachment path extending from leaflet nadirs at upstream ends of saidreplacement leaflets to leaflet commissures at downstream ends of saidreplacement leaflets, B. delivering said stent-valve frame within theheart such that a ventricular portion of said stent-valve frame extendsinto a ventricle and an atrial portion extends into an atrium, C.positioning said stent-valve frame proximate to the native mitralvalvular tissues such that a securement band extending around aperimeter of said stent-valve frame is located intermediate between saidatrial portion and said ventricular portion, said securement bandsecuring said stent-valve frame to prevent migration relative to thenative mitral valvular tissues and preventing leakage of blood around anouter surface of said stent-valve frame, D. providing a ventricularpassage for blood flow in an outward direction through a ventricularopen frame surface of said stent-valve frame, said ventricular openframe surface being free of said covering, said ventricular open framesurface being located downstream of said securement band, upstream ofsaid leaflet commissures, and located radially outward from saidreplacement leaflets.
 2. The method of claim 1 wherein said stent-valveframe has an atrial open frame surface in said atrial portion of saidstent-valve frame, said atrial open frame surface being free of saidcovering, said method comprising the step of providing an atrial passagefor blood flow in an inward direction through said open atrial surfaceof said stent-valve frame at a location upstream of said securementband, downstream of said leaflet nadirs, and at a location radiallyoutwards between two neighboring leaflets.
 3. The method of claim 1wherein said securement band has a securement band height in the axialdirection that ranges from 1-10 mm, said securement band having saidcovering attached thereto.
 4. The method of claim 1 wherein the bloodflow in the outward direction is directed from a central region of saidstent-valve frame across said ventricular open frame surface into theventricle at a location upstream of said leaflet commissures.
 5. Themethod of claim 2 wherein the blood flow in the inward direction isdirected from the atrium across said atrial open frame surface into acentral region of said stent-valve frame at a location downstream ofsaid leaflet nadirs thereby reducing stagnation of blood in the atriumbetween an atrial wall and said stent-valve frame.
 6. The method ofclaim 1 wherein said ventricular open frame surface is devoid of saidstent-valve frame.
 7. The method of claim 2 wherein said atrial openframe surface is devoid of said stent-valve frame.
 8. The method ofclaim 1 wherein said securement band secures said stent-valve frame toan external support frame, said external support frame being fixedlyattached to a base or rim of native mitral leaflets, or attachedupstream of the native mitral leaflets such that function of nativemitral leaflets is maintained with said external support frame beingfixedly attached.
 9. The method of claim 8 wherein said external supportframe provides a closed ring into which said stent-valve frame isattached to form a sealing contact to prevent leakage of blood betweensaid stent-valve frame and said external support frame and to preventmigration of said stent-valve frame relative to said external supportframe.
 10. The method of claim 9 wherein said external support frame hasan expandable frame that expands from a smaller diameter configurationduring delivery to a larger diameter configuration, said externalsupport frame being fixedly attached in said larger diameterconfiguration to the native mitral valvular tissues via barbs orfixation members activated by a torus balloon.
 11. The method forproviding a passage for blood flow through a surface of a stent-valveframe such that the blood flow reduces thrombosis or stagnation regionsnear said stent-valve frame, the stent-valve frame being implanted viatranscatheter implantation into native valvular tissues of a heart, saidstent-valve frame being an expandable stent-valve frame that isdelivered in a smaller diameter configuration and able to expand out toa larger diameter configuration, said stent-valve frame havingreplacement leaflets attached to said stent-valve frame, said methodcomprising, A. providing a stent-valve frame wherein said replacementleaflets are attached to said stent-valve frame along a crown-shapedattachment path extending from leaflet nadirs at upstream ends of saidreplacement leaflets to leaflet commissures at downstream ends of saidreplacement leaflets, said stent-valve frame having a covering attachedto at least a portion of said stent-valve frame, B. placing saidstent-valve frame within the heart such that a ventricular portion ofsaid stent-valve frame extends into a ventricle and an atrial portionextends into an atrium by at least 35 percent of a stent-valve frameaxial length, C. positioning said stent-valve frame proximate to thenative valvular tissues such that a securement band extending around aperimeter of said stent-valve frame is located between said atrialportion and said ventricular portion, said securement band securing saidstent-valve frame to prevent migration relative to the native mitralvalvular tissues, and prevent blood leakage between said securement bandand the native mitral valvular tissues, D. providing an atrial passagefor an inward flow of blood through an atrial open frame surface of saidstent-valve frame, said atrial open frame surface being free of saidcovering, said ventricular open frame surface being located upstream ofsaid securement band, downstream of said leaflet nadirs, and locatedalong said stent-valve frame at a location between two neighboring ofsaid replacement leaflets.
 12. The method of claim 11 wherein saidstent-valve frame has a ventricular open frame surface in saidventricular portion of said stent-valve frame, said ventricular openframe surface being free of said covering, said method comprising thestep of providing a ventricular passage for an outward flow of bloodthrough said ventricular open frame surface of said stent-valve frame ata location downstream of said securement band, upstream of said leafletcommissures, and radially outwards from said replacement leaflets. 13.The method of claim 11 wherein said securement band has a securementband height in the axial direction of 1-10 mm, said securement bandhaving a covering attached thereto.
 14. The method of claim 11 whereinthe inward flow of blood is delivered from the atrium across said atrialopen frame surface into a central region of said stent-valve frame at alocation downstream of said leaflet nadirs.
 15. The method of claim 12wherein the outward flow of blood is delivered from a central region ofsaid stent-valve frame across said ventricular open frame surface intothe ventricle at a location upstream of said leaflet commissures. 16.The method of claim 11 wherein said atrial open frame surface is devoidof said stent-valve frame.
 17. The method of claim 12 wherein saidventricular open frame surface is devoid of said stent-valve frame. 18.The method of claim 11 wherein said securement band secures saidstent-valve frame to an external support frame, said external supportframe being fixedly attached to the native valvular tissues of theheart, wherein the external support frame is positioned at or upstreamof native leaflet cusps thereby maintaining function of the nativeleaflet cusps after the external support frame has been fixedly attachedand implanted into the heart.
 19. The method of claim 18 wherein saidexternal support frame provides a closed ring into which saidstent-valve frame forms a sealing contact and securement to preventleakage of blood flow between and to prevent relative movement betweensaid stent-valve frame and said external support frame.
 20. The methodof claim 19 wherein said external support frame has an expandable framethat expands from a smaller diameter configuration to a larger diameterconfiguration, said external support frame being fixedly attached to thenative valvular tissues using a torus balloon that is permanentlyaffixed to said external support frame.